Food and Drug Administration, HHS Pt. 74
(acetylamino)-4-hydroxy-3-((4-((2- requirements of section 721(c) of the (sulfooxy)ethyl)sulfonyl)phenyl)azo)-] act. (CAS Reg. No. 68189–39–9). [58 FR 3227, Jan. 8, 1993, as amended at 58 FR (4) C.I. Reactive Yellow 15 17510, Apr. 5, 1993] [benzenesulfonic acid, 4-(4,5-dihydro-4- ((2-methoxy-5-methyl-4-((2- PART 74—LISTING OF COLOR AD- (sulfooxy)ethyl)sulfonyl)phenyl)azo)-3- DITIVES SUBJECT TO CERTIFI- methyl-5-oxo-1H-pyrazol-1-yl)-] (CAS CATION Reg. No. 60958–41–0). (5) C.I. Reactive Blue No. 19 [2- Subpart A—Foods anthracenesulfonic acid, 1-amino-9,10- dihydro-9,10-dioxo-4-((3-((2- Sec. (sulfooxy)ethyl)sulfonyl)phenyl)amino) 74.101 FD&C Blue No. 1. -, disodium salt] (CAS Reg. No. 2580–78– 74.102 FD&C Blue No. 2. 74.203 FD&C Green No. 3. 1). 74.250 Orange B. (6) C.I. Reactive Blue 21 [copper, 74.302 Citrus Red No. 2. (29H,31H-phthalocyaninato(2-)-N29, N30, 74.303 FD&C Red No. 3. N31, N32)-, sulfo((4-((2-(sulfooxy) 74.340 FD&C Red No. 40. ethyl)sulfonyl)phenyl)amino)sulfonyl 74.705 FD&C Yellow No. 5. derivatives] (CAS Reg. No. 73049–92–0). 74.706 FD&C Yellow No. 6. (b) Uses and restrictions. (1) The sub- Subpart B—Drugs stances listed in paragraph (a) of this section may be used to color contact 74.1101 FD&C Blue No. 1. lenses in amounts not to exceed the 74.1102 FD&C Blue No. 2. 74.1104 D&C Blue No. 4. minimum reasonably required to ac- 74.1109 D&C Blue No. 9. complish the intended coloring effect. 74.1203 FD&C Green No. 3. (2) As part of the manufacturing 74.1205 D&C Green No. 5. process, the lenses containing the color 74.1206 D&C Green No. 6. additives are thoroughly washed to re- 74.1208 D&C Green No. 8. move unbound reactive dye. 74.1254 D&C Orange No. 4. 74.1255 D&C Orange No. 5. (3) Authorization and compliance 74.1260 D&C Orange No. 10. with this use shall not be construed as 74.1261 D&C Orange No. 11. waiving any of the requirements of sec- 74.1303 FD&C Red No. 3. tions 510(k), 515, and 520(g) of the Fed- 74.1304 FD&C Red No. 4. eral Food, Drug, and Cosmetic Act (the 74.1306 D&C Red No. 6. act). A person intending to introduce a 74.1307 D&C Red No. 7. 74.1317 D&C Red No. 17. device containing a vinyl alcohol/meth- 74.1321 D&C Red No. 21. yl methacrylate-dye reaction product 74.1322 D&C Red No. 22. listed under this section into com- 74.1327 D&C Red No. 27. merce shall submit to the Food and 74.1328 D&C Red No. 28. Drug Administration either a pre- 74.1330 D&C Red No. 30. market notification in accordance with 74.1331 D&C Red No. 31. subpart E of part 807 of this chapter, if 74.1333 D&C Red No. 33. 74.1334 D&C Red No. 34. the device is not subject to premarket 74.1336 D&C Red No. 36. approval, or submit and receive ap- 74.1339 D&C Red No. 39. proval of an original or supplemental 74.1340 FD&C Red No. 40. premarket approval application if the 74.1602 D&C Violet No. 2. device is subject to premarket ap- 74.1705 FD&C Yellow No. 5. proval. 74.1706 FD&C Yellow No. 6. 74.1707 D&C Yellow No. 7. (c) Labeling. The label of the color ad- 74.1707a Ext. D&C Yellow No. 7. ditive shall conform to the require- 74.1708 D&C Yellow No. 8. ments of § 70.25 of this chapter. 74.1710 D&C Yellow No. 10. (d) Exemption from certification. Cer- 74.1711 D&C Yellow No. 11. tification of this color additive is not necessary for the protection of the pub- Subpart C—Cosmetics lic health, and therefore, this color ad- 74.2101 FD&C Blue No. 1. ditive is exempt from the certification 74.2104 D&C Blue No. 4.
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74.2151 D&C Brown No. 1. sulfobenzyl) ammonium hydroxide 74.2203 FD&C Green No. 3. inner salt and ethyl [4-[p-[ethyl (o- 74.2205 D&C Green No. 5. α 74.2206 D&C Green No. 6. sulfobenzyl) amino] - - (o 74.2208 D&C Green No. 8. -sulfophenyl) benzylidene]-2,5- 74.2254 D&C Orange No. 4. cyclohexadien-1-ylidene] (o- 74.2255 D&C Orange No. 5. sulfobenzyl) ammonium hydroxide 74.2260 D&C Orange No. 10. inner salt. 74.2261 D&C Orange No. 11. 74.2304 FD&C Red No. 4. (2) Color additive mixtures for food 74.2306 D&C Red No. 6. use (including dietary supplements) 74.2307 D&C Red No. 7. made with FD&C Blue No. 1 may con- 74.2317 D&C Red No. 17. tain only those diluents that are suit- 74.2321 D&C Red No. 21. able and that are listed in part 73 of 74.2322 D&C Red No. 22. 74.2327 D&C Red No. 27. this chapter as safe for use in color ad- 74.2328 D&C Red No. 28. ditive mixtures for coloring foods. 74.2330 D&C Red No. 30. (b) Specifications. FD&C Blue No. 1 74.2331 D&C Red No. 31. shall conform to the following speci- 74.2333 D&C Red No. 33. fications and shall be free from impuri- 74.2334 D&C Red No. 34. 74.2336 D&C Red No. 36. ties other than those named to the ex- 74.2340 FD&C Red No. 40. tent that such other impurities may be 74.2602 D&C Violet No. 2. avoided by current good manufacturing 74.2602a Ext. D&C Violet No. 2. practice: 74.2705 FD&C Yellow No. 5. 74.2706 FD&C Yellow No. 6. Sum of volatile matter (at 135 ° C) and 74.2707 D&C Yellow No. 7. chlorides and sulfates (calculated as so- 74.2707a Ext. D&C Yellow No. 7. dium salts), not more than 15.0 percent. 74.2708 D&C Yellow No. 8. Water-insoluble matter, not more than 0.2 74.2710 D&C Yellow No. 10. percent. 74.2711 D&C Yellow No. 11. Leuco base, not more than 5 percent. Subpart D–Medical Devices Sum of o-, m-, and p-sulfobenzaldehydes, not more than 1.5 percent. 74.3045 [Phthalocyaninato(2-)] copper. N-Ethyl,N-(m-sulfobenzyl)sulfanilic acid, not 74.3106 D&C Blue No. 6. more than 0.3 percent. 74.3206 D&C Green No. 6. Subsidiary colors, not more than 6.0 percent. 74.3230 D&C Red No. 17. Chromium (as Cr), not more than 50 parts 74.3602 D&C Violet No. 2. per million. 74.3710 D&C Yellow No. 10. Manganese (as Mn), not more than 100 parts APPENDIX A TO PART 74—THE PROCEDURE FOR per million. DETERMINING ETHER SOLUBLE MATERIAL Arsenic (as As), not more than 3 parts per IN D&C RED NOS. 6 AND 7 million. AUTHORITY: 21 U.S.C. 321, 341, 342, 343, 348, Lead (as Pb), not more than 10 parts per mil- 351, 352, 355, 361, 362, 371, 379e. lion. SOURCE: 42 FR 15654, Mar. 22, 1977, unless Total color, not less than 85.0 percent. otherwise noted. (c) Uses and restrictions. FD&C Blue No. 1 may be safely used for coloring Subpart A—Foods foods (including dietary supplements) § 74.101 FD&C Blue No. 1. generally in amounts consistent with good manufacturing practice except (a) Identity. (1) The color additive that it may not be used to color foods FD&C Blue No. 1 is principally the di- sodium salt of ethyl [4-[p-[ethyl (m- for which standards of identity have sulfobenzyl) amino]-α-(o-sulfophenyl) been promulgated under section 401 of benzylidene] - 2,5 -cyclohexadien - 1 - the act unless added color is authorized ylidene] (m-sulfobenzyl) ammonium hy- by such standards. droxide inner salt with smaller (d) Labeling. The label of the color ad- amounts of the isomeric disodium salts ditive and any mixtures prepared of ethyl [4-[p-[ethyl(p-sulfobenzyl) therefrom intended solely or in part for amino]-α-(o-sulfophenyl) benzylidene]- coloring purposes shall conform to the 2,5-cyclohexadien-1-ylidene] (p- requirements of § 70.25 of this chapter.
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(e) Certification. All batches of FD&C Disodium salt of 2-(1,3-dihydro-3-oxo-7-sulfo- Blue No. 1 shall be certified in accord- 2H-indol-2-ylidene)-2,3-dihydro-3-oxo-1H- ance with regulations in part 80 of this indole-5-sulfonic acid, not more than 18 percent. chapter. Sodium salt of 2-(1,3-dihydro-3-oxo-2H-indol- [42 FR 15654, Mar. 22, 1977, as amended at 58 2-ylidene)-2,3-dihydro-3-oxo-1H-indole-5- FR 17511, Apr. 5, 1993] sulfonic acid, not more than 2 percent. Lead (as Pb), not more than 10 parts per mil- lion. § 74.102 FD&C Blue No. 2. Arsenic (as As), not more than 3 parts per (a) Identity. (1) The color additive million. FD&C Blue No. 2 is principally the di- Mercury (as Hg), not more than 1 part per sodium salt of 2-(1,3-dihydro-3-oxo-5- million. Total color, not less than 85 percent. sulfo-2H-indol-2-ylidene)-2,3-dihydro-3- oxo-1H-indole-5-sulfonic acid (CAS Reg. (c) Uses and restrictions. The color ad- No. 860–22–0) with smaller amounts of ditive FD&C Blue No. 2 may be safely the disodium salt of 2-(1,3-dihydro-3- used for coloring foods (including die- oxo-7-sulfo-2H-indol-2-ylidene)-2,3- tary supplements) generally in dihydro-3-oxo-1H-indole-5-sulfonic acid amounts consistent with current good (CAS Reg. No. 54947–75–0) and the so- manufacturing practice except that it dium salt of 2-(1,3-dihydro-3-oxo-2H- may not be used to color foods for indol-2-ylidene)-2,3-dihydro-3-oxo-1H- which standards of identity have been indole-5-sulfonic acid (CAS Reg. No. promulgated under section 401 of the 605–18–5). Additionally, FD&C Blue No. Federal Food, Drug, and Cosmetic Act 2 is obtained by heating indigo (or in- unless added color is authorized by digo paste) in the presence of sulfuric such standards. acid. The color additive is isolated and (d) Labeling. The label of the color ad- subjected to purification procedures. ditive and any mixtures prepared The indigo (or indigo paste) used above therefrom intended solely or in part for is manufactured by the fusion of N- coloring purposes shall conform to the phenylglycine (prepared from aniline requirements of § 70.25 of this chapter. and formaldehyde) in a molten mixture (e) Certification. All batches of FD&C of sodamide and sodium and potassium Blue No. 2 shall be certified in accord- hydroxides under ammonia pressure. ance with regulations in part 80 of this The indigo is isolated and subjected to chapter. purification procedures prior to [48 FR 5260, Feb. 4, 1983] sulfonation. (2) Color additive mixtures for food § 74.203 FD&C Green No. 3. use (including dietary supplements) (a) Identity. (1) The color additive made with FD&C Blue No. 2 may con- FD&C Green No. 3 is principally the tain only those diluents that are suit- inner salt disodium salt of N-ethyl-N- able and that are listed in part 73 of [4-[[4-[ethyl[(3- this chapter as safe for use in color ad- sulfophenyl)methyl]amino]phenyl](4- ditive mixtures for coloring foods. hydroxy-2-sulfophenyl)methylene]-2,5- (b) Specifications. The color additive cyclohexadien-1-ylidene]-3- FD&C Blue No. 2 shall conform to the sulfobenzenemethanaminium hydrox- following specifications and shall be ide (CAS Reg. No. 2353–45–9); with free from impurities other than those smaller amounts of the isomeric inner named to the extent that such other salt disodium salt of N-ethyl-N-[4-[[4- impurities may be avoided by current [ethyl[(3-sulfophenyl)methyl] good manufacturing practice: amino]phenyl](4-hydroxy-2- sulfophenyl)methylene]-2,5- ° ° Sum of volatile matter at 135 C (275 F) and cyclohexadien-1-ylidene]-4- chlorides and sulfates (calculated as so- dium salts), not more than 15 percent. sulfobenzenemethanaminium hydrox- Water insoluble matter, not more than 0.4 ide; of N-ethyl-N-[4-[[4-[ethyl[(4- percent. sulfophenyl)methyl]amino]phenyl](4- Isatin-5-sulfonic acid, not more than 0.4 per- hydroxy-2-sulfophenyl)methylene]-2,5- cent. cyclohexadien-1-ylidene]-4- 5-Sulfoanthranilic acid, not more than 0.2 sulfobenzenemethanaminium hydrox- percent. ide and of N-ethyl-N-[4-[[4-[ethyl[(2-
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sulfophenyl)methyl]amino]phenyl](4- Chromium (as Cr), not more than 50 parts hydroxy-2-sulfophenyl)methylene]-2,5- per million. cyclohexadien-1-ylidene]-3- Arsenic (as As), not more than 3 parts per sulfobenzenemethanaminium hydrox- million. Lead (as Pb), not more than 10 parts per mil- ide. Additionally, FD&C Green No. 3 is lion. manufactured by the acid catalyzed Mercury (as Hg), not more than 1 part per condensation of one molecule of 2- million. formyl-5-hydroxybenzenesulfonic acid Total color, not less than 85 percent. with two molecules from a mixture (c) Uses and restrictions. The color ad- consisting principally of 3- ditive FD&C Green No. 3 may be safely [(ethylphenylamino)methyl] used for coloring foods (including die- benzensulfonic acid, and smaller tary supplements) generally in amounts of 4- amounts consistent with current good [(ethylphenylamino)methyl] manufacturing practice except that it benzenesulfonic acid and 2- may not be used to color foods for [(ethylphenylamino)methyl] which standards of identity have been benzenesulfonic acid to form the leuco promulgated under section 401 of the base. The leuco base is then oxidized act unless added color is authorized by with lead dioxide and acid or with di- such standards. chromate and acid to form the dye. The (d) Labeling. The label of the color ad- intermediate 2-formyl-5- ditive and any mixtures prepared hydroxybenzenesulfonic acid is pre- therefrom intended solely or in part for pared by the potassium permanganate coloring purposes shall conform to the oxidation of 2,2′-(1,2-ethenediyl)-bis(5- requirements of § 70.25 of this chapter. aminobenzenesulfonic acid) to sodium (e) Certification. All batches of FD&C 5-amino-2-formylbenzenesulfonate. Green No. 3 shall be certified in accord- This amine is diazotized and the result- ance with regulations in part 80 of this ing diazonium salt is hydrolyzed to the chapter. desired 2-formyl-5- [47 FR 52143, Nov. 19, 1982; 47 FR 56489, Dec. hydroxybenzenesulfonic acid. 17, 1982] (2) Color additive mixtures for food use (including dietary supplements) § 74.250 Orange B. made with FD&C Green No. 3 may con- (a) Identity. (1) The color additive Or- tain only those diluents that are suit- ange B is principally the disodium salt able and that are listed in part 73 of of 1-(4-sulfophenyl)-3-ethylcarboxy-4-(4- this chapter as safe for use in color ad- sulfonaphthylazo)-5-hydro-xypyrazole. ditive mixtures for coloring food. (2) The diluents in color additive (b) Specifications. The color additive mixtures for food use containing Or- FD&C Green No. 3 shall conform to the ange B are limited to those listed in following specifications and shall be part 73 of this chapter as safe and suit- free from impurities other than those able in color additive mixtures for named to the extent that such other coloring foods. impurities may be avoided by current (b) Specifications. Orange B shall con- good manufacturing practice: form to the following specifications: Sum of volatile matter at 135 °C (275 °F) and Volatile matter (at 135 °C.), not more than chlorides and sulfates (calculated as so- 6.0 percent. dium salts), not more than 15 percent. Chlorides and sulfates (calculated as the so- Water-insoluble matter, not more than 0.2 dium salts), not more than 7.0 percent. percent. Water insoluble matter, not more than 0.2 Leuco base, not more than 5 percent. percent. Sum of 2-,3-,4-formylbenzenesulfonic acids, 1-(4-Sulfophenyl)-3-ethylcarboxy-5- sodium salts, not more than 0.5 percent. hydroxypyrazolone and 1-(4-sulfophenyl)-3- Sum of 3- and 4-[[ethyl(4- carboxy-5-hydroxypyrazolone, not more sulfophenyl)amino]methyl] than 0.7 percent. benzenesulfonic acid, disodium salts, not Naphthionic acid, not more than 0.2 percent. more than 0.3 percent. Phenylhydrazine-p-sulfonic acid, not more 2-Formyl-5-hydroxybenzenesulfonic acid, so- than 0.2 percent. dium salt, not more than 0.5 percent. The trisodium salt of 1-(4-sulfophenyl)-3- Subsidiary colors, not more than 6 percent. carboxy-4-(4-sulfonaphthylazo)-5-
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hydroxypyrazole, not more than 6.0 per- Subsidiary dyes, not more than 2.0 percent. cent. Lead (as Pb), not more than 10 parts per mil- Other subsidiary dyes, not more than 1.0 per- lion. cent. Arsenic (as As), not more than 1 part per Lead (as Pb), not more than 10 parts per mil- million. lion. Total color, not less than 98 percent. Arsenic (as As), not more than 1 part per million. (c) Uses and restrictions. (1) Citrus Red Total color, not less than 87.0 percent. No. 2 shall be used only for coloring the (c) Uses and restrictions. Orange B skins of oranges that are not intended may be safely used for coloring the cas- or used for processing (or if so used are ings or surfaces of frankfurters and designated in the trade as Packinghouse sausages subject to the restriction that elimination) and that meet minimum the quantity of the color additive does maturity standards established by or not exceed 150 parts per million by under the laws of the States in which weight of the finished food. the oranges are grown. (d) Labeling requirements. The label of (2) Oranges colored with Citrus Red the color additive and any mixtures in- No. 2 shall bear not more than 2.0 parts tended solely or in part for coloring purposes prepared therefrom shall con- per million of such color additive, cal- form to the requirements of § 70.25 of culated on the basis of the weight of this chapter. the whole fruit. (e) Certification. All batches of Orange (d) Labeling. The label of the color ad- B shall be certified in accordance with ditive and any mixtures prepared regulations promulgated under part 80 therefrom and intended solely or in of this chapter. part for coloring purposes shall con- form to the requirements of § 70.25 of § 74.302 Citrus Red No. 2. this chapter. To meet the requirements (a) Identity. (1) The color additive of § 70.25 (b) and (c) of this chapter the Citrus Red No. 2 is principally 1–(2,5– label shall bear: dimethoxyphenylazo)-2-naphthol. (1) The statement (or its equivalent) (2) The following diluents may be ‘‘To be used only for coloring skins of used in aqueous suspension, in the per- oranges.’’ centages specified, to facilitate appli- (2) Directions for use to limit the cation to oranges in accordance with amount of the color additive to not paragraph (c)(1) of this section: (i) Suitable diluents used in accord- more than 2.0 parts per million, cal- ance with § 73.1(a) of this chapter. culated on the basis of the weight of (ii) Volatile solvents that leave no the whole fruit. residue after application to the orange. (e) Certification. All batches of Citrus (iii) Salts of fatty acids meeting the Red No. 2 shall be certified in accord- requirements of § 172.863 of this chap- ance with regulations in part 80 of this ter. chapter. (iv) Sodium tripolyphosphate, not more than 0.05 percent. § 74.303 FD&C Red No. 3. (b) Specifications. Citrus Red No. 2 (a) Identity. (1) The color additive shall conform to the following speci- FD&C Red No. 3 is principally the fications and shall be free from impuri- monohydrate of 9 (o- carboxyphenyl)-6- ties, other than those named, to the ex- hydroxy - 2,4,5,7-tetraiodo-3H-xanthen- tent that such other impurities may be 3-one, disodium salt, with smaller avoided by good manufacturing prac- tice: amounts of lower imdinated fluoresceins. Volatile matter (at 100 °C.), not more than (2) Color additive mixtures for food 0.5 percent. Water-soluble matter, not more than 0.3 per- use made with FD&C Red No. 3 may cent. contain only those diluents that are Matter insoluble in carbon tetrachloride, not suitable and that are listed in part 73 more than 0.5 percent. of this chapter as safe for use in color Uncombined intermediates, not more than additive mixtures for coloring foods. 0.05 percent.
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(b) Specifications. FD&C Red No. 3 (3) The listing of this color additive shall conform to the following speci- includes lakes prepared as described in fications and shall be free from impuri- § 82.51 of this chapter, except that the ties other than those named to the ex- color additive used is FD&C Red No. 40 tent that such other impurities may be and the resultant lakes meet the speci- avoided by good manufacturing prac- fication and labeling requirements pre- tice: scribed by § 82.51 of this chapter. Volatile matter (at 135 °C.) and chlorides and (b) Specifications. FD&C Red No. 40 sulfates (calculated as the sodium salts), shall conform to the following speci- total not more than 13 percent. fications and shall be free from impuri- Water-insoluble matter, not more than 0.2 ties other than those named to the ex- percent. tent that such other impurities may be Unhalogenated intermediates, total not avoided by good manufacturing prac- more than 0.1 percent. tice: Sodium iodide, not more than 0.4 percent. Triiodoresorcinol, not more than 0.2 percent. Sum of volatile matter (at 135 °C.) and 2(2′,4′-Dihydroxy-3′, 5′-diiodobenzoyl) benzoic chlorides and sulfates (calculated as so- acid, not more than 0.2 percent. dium salts), not more than 14.0 percent. Monoiodofluoresceins not more than 1.0 per- Water-insoluble matter, not more than 0.2 cent. percent. Other lower iodinated fluoresceins, not more Higher sulfonated subsidiary colors (as so- than 9.0 percent. dium salts), not more than 1.0 percent. Lead (as Pb), not more than 10 parts per mil- Lower sulfonated subsidiary colors (as so- lion. dium salts), not more than 1.0 percent. Arsenic (as As), not more than 3 parts per Disodium salt of 6-hydroxy-5-[(2-methoxy-5- million. methyl-4-sulfophenyl) azo] -8-(2-methoxy-5- Total color, not less than 87.0 percent. methyl-4-sulfophenoxy)-2- (c) Uses and restrictions. FD&C Red naphthalenesulfonic acid, not more than 1.0 percent. No. 3 may be safely used for coloring Sodium salt of 6-hydroxy-2- foods generally (including dietary sup- naphthalenesulfonic acid (Schaeffer’s salt), plements) in amounts consistent with not more than 0.3 percent. good manufacturing practice except 4-Amino-5-methoxy-o- toluenesulfonic acid, that it may not be used to color foods not more than 0.2 percent. for which standards of identity have Disodium salt of 6,6′-oxybis (2-naphthalene- been promulgated under section 401 of sulfonic acid), not more than 1.0 percent. the act unless added color is authorized Lead (as Pb), not more than 10 parts per mil- by such standards. lion. (d) Labeling. The label of the color ad- Arsenic (as As), not more than 3 parts per ditive and any mixtures prepared million. Total color, not less than 85.0 percent. therefrom intended solely or in part for coloring purposes shall conform to the (c) Uses and restrictions. FD&C Red requirements of § 70.25 of this chapter. No. 40 may be safely used for coloring (e) Certification. All batches of FD&C foods (including dietary supplements) Red No. 3 shall be certified in accord- generally in amounts consistent with ance with regulations in part 80 of this good manufacturing practice except chapter. that it may not be used to color foods for which standards of identity have § 74.340 FD&C Red No. 40. been promulgated under section 401 of (a) Identity. (1) The color additive the act unless added color is authorized FD&C Red No. 40 is principally the di- by such standards. sodium salt of 6-hydroxy-5-[(2- (d) Labeling. The label of the color ad- methoxy-5-methyl-4-sulfophenyl)azo]-2- ditive and any lakes or mixtures pre- naphthalenesulfonic acid. pared therefrom intended solely or in (2) Color additive mixtures for food part for coloring purposes shall con- use (including dietary supplements) form to the requirements of § 70.25 of made with FD&C Red No. 40 may con- this chapter. tain only those diluents that are suit- (e) Certification. All batches of FD&C able and that are listed in part 73 of Red No. 40 and lakes thereof shall be this chapter as safe for use in color ad- certified in accordance with regula- ditive mixtures for coloring foods. tions in part 80 of this chapter.
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§ 74.705 FD&C Yellow No. 5. 4,4′-(1-Triazene-1,3-diyl)bis[benzenesulfonic acid], disodium salt, not more than 0.05 (a) Identity. (1) The color additive percent. FD&C Yellow No. 5 is principally the 4-Aminoazobenzene, not more than 75 parts trisodium salt of 4,5-dihydro-5-oxo-1-(4- per billion. sulfophenyl)-4-[4-sulfophenyl-azo]-1H- 4-Aminobiphenyl, not more than 5 parts per pyrazole-3-carboxylic acid (CAS Reg. billion. Aniline, not more than 100 parts per billion. No. 1934–21–0). To manufacture the ad- Azobenzene, not more than 40 parts per bil- ditive, 4-amino-benzenesulfonic acid is lion. diazotized using hydrochloric acid and Benzidine, not more than 1 part per billion. sodium nitrite. The diazo compound is 1,3-Diphenyltriazene, not more than 40 parts coupled with 4,5-dihydro-5-oxo-1-(4- per billion. sulfophenyl)-1H-pyrazole-3-carboxylic Lead (as Pb), not more than 10 parts per mil- lion. acid or with the methyl ester, the Arsenic (as As), not more than 3 parts per ethyl ester, or a salt of this carboxylic million. acid. The resulting dye is purified and Mercury (as Hg), not more than 1 part per isolated as the sodium salt. million. (2) Color additive mixtures for food Total color, not less than 87 percent. use made with FD&C Yellow No. 5 may (c) Uses and restrictions. FD&C Yellow contain only those diluents that are No. 5 may be safely used for coloring suitable and that are listed in part 73 foods (including dietary supplements) of this chapter as safe for use in color generally in amounts consistent with additive mixtures for coloring foods. good manufacturing practice, except (b) Specifications. FD&C Yellow No. 5 that it may not be used to color foods shall conform to the following speci- for which standards of identity have fications and shall be free from impuri- been promulgated under section 401 of ties other than those named to the ex- the act unless added color is authorized tent that such other impurities may be by such standards. avoided by good manufacturing prac- (d) Labeling requirements. (1) The label tice: of the color additive and any mixtures intended solely or in part for coloring Sum of volatile matter at 135 ° C (275 ° F) and purposes prepared therefrom shall con- chlorides and sulfates (calculated as so- form to the requirements of § 70.25 of dium salts), not more than 13 percent. this chapter. Water-insoluble matter, not more than 0.2 (2) Foods for human use that contain percent. FD&C Yellow No. 5, including butter, 4,4′-[4,5-Dihydro-5-oxo-4-[(4- sulfophenyl)hydrazono]-1H-pyrazol-1,3- cheese, and ice cream, shall specifi- diyl]bis[benzenesulfonic acid], trisodium cally declare the presence of FD&C salt, not more than 1 percent. Yellow No. 5 by listing the color addi- 4-[(4′,5-Disulfo[1,1′-biphenyl]-2-yl)hydrazono]- tive as FD&C Yellow No. 5 among the 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyr- list of ingredients. azole-3-carboxylic acid, tetrasodium salt, (e) Certification. All batches of FD&C not more than 1 percent. Yellow No. 5 shall be certified in ac- Ethyl or methyl 4,5-dihydro-5-oxo-1-(4- cordance with regulations in part 80 of sulfophenyl)-4-[(4-sulfophenyl)hydrazono]- this chapter. 1H-pyrazole-3-carboxylate, disodium salt, not more than 1 percent. [42 FR 15654, Mar. 22, 1977; 44 FR 17658, Mar. Sum of 4,5-dihydro-5-oxo-1-phenyl-4-[(4- 23, 1979, as amended at 44 FR 37220, June 26, sulfophenyl)azo]-1H-pyrazole-3-carboxylic 1979; 51 FR 24519, July 7, 1986] acid, disodium salt, and 4,5-dihydro-5-oxo- 4-(phenylazo)-1-(4-sulfophenyl)-1H-pyr- § 74.706 FD&C Yellow No. 6. azole-3-carboxylic acid, disodium salt, not (a) Identity. (1) The color additive more than 0.5 percent. FD&C Yellow No. 6 is principally the 4-Aminobenzenesulfonic acid, sodium salt, disodium salt of 6-hydroxy-5-[(4- not more than 0.2 percent. sulfophenyl)azo]-2-naphthalenesulfonic 4,5-Dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyr- azole-3-carboxylic acid, disodium salt, not acid (CAS Reg. No. 2783–94–0). The tri- more than 0.2 percent. sodium salt of 3-hydroxy-4-[(4- Ethyl or methyl 4,5-dihydro-5-oxo-1-(4- sulfophenyl)azo]-2,7- sulfophenyl)-1H-pyrazole-3-carboxylate, so- naphthalenedisulfonic acid (CAS Reg. dium salt, not more than 0.1 percent. No. 50880–65–4) may be added in small
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amounts. The color additive is manu- 1,3-Diphenyltriazene, not more than 40 parts factured by diazotizing 4- per billion. aminobenzenesulfonic acid using hy- 1-(Phenylazo)-2-naphthalenol, not more than drochloric acid and sodium nitrite or 10 parts per million. Lead (as Pb), not more than 10 parts per mil- sulfuric acid and sodium nitrite. The lion. diazo compound is coupled with 6-hy- Arsenic (as As), not more than 3 parts per droxy-2-naphthalene-sulfonic acid. The million. dye is isolated as the sodium salt and Mercury (as Hg), not more than 1 part per dried. The trisodium salt of 3-hydroxy- million. 4-[(4-sulfophenyl)azo]-2,7- Total color, not less than 87 percent. naphthalenedisulfonic acid which may (c) Uses and restrictions. The color ad- be blended with the principal color is ditive FD&C Yellow No. 6 may be safe- prepared in the same manner except ly used for coloring foods (including di- the diazo benzenesulfonic acid is cou- etary supplements) generally in pled with 3-hydroxy-2,7- amounts consistent with current good naphthalenedisulfonic acid. manufacturing practice, except that it (2) Color additive mixtures for food may not be used to color foods for use made with FD&C Yellow No. 6 may which standards of identity have been contain only those diluents that are promulgated under section 401 of the suitable and that are listed in part 73 act unless added color is authorized by of this chapter as safe for use in color such standards. additive mixtures for coloring foods. (d) Labeling requirements. (1) The label (b) Specifications. The color additive of the color additive and any mixtures FD&C Yellow No. 6 shall conform to intended solely or in part for coloring the following specifications and shall purposes prepared therefrom shall con- be free from impurities other than form to the requirements of § 70.25 of those named to the extent that such this chapter. other impurities may be avoided by (2) [Reserved] current good manufacturing practice: (e) Certification. All batches of FD&C Sum of volatile matter (at 135 °C) and Yellow No. 6 shall be certified in ac- chlorides and sulfates (calculated as so- cordance with regulations in part 80 of dium salts), not more than 13 percent. this chapter. Water insoluble matter, not more than 0.2 percent. [51 FR 41782, Nov. 19, 1986, as amended at 52 Sodium salt of 4-aminobenzenesulfonic acid, FR 21508, June 8, 1987; 53 FR 49138, Dec. 6, not more than 0.2 percent. 1988] Sodium salt of 6-hydroxy-2- naphthalenesulfonic acid, not more than Subpart B—Drugs 0.3 percent. Disodium salt of 6,6′-oxybis[2- § 74.1101 FD&C Blue No. 1 naphthalenesulfonic acid], not more than 1 percent. (a) Identity. (1) For ingested drugs, Disodium salt of 4,4′-(1-triazene-1,3- the color additive FD&C Blue No. 1 diyl)bis[benzenesulfonic acid], not more shall conform in identity to the re- than 0.1 percent. quirements of § 74.101(a)(1). Sum of the sodium salt of 6-hydroxy-5- (2) For externally applied drugs, the (phenylazo)-2-naphthalenesulfonic acid and color additive FD&C Blue No. 1 shall the sodium salt of 4-[(2-hydroxy-1- conform in identity to the require- naphthalenyl)azo]benzenesulfonic acid, not more than 1 percent. ments of § 74.2101(a). Sum of the trisodium salt of 3-hydroxy-4-[(4- (3) Color additive mixtures for drug sulfophenyl)azo]-2,7-naphthalenedisulfonic use made with FD&C Blue No. 1 may acid and other higher sulfonated subsidi- contain only those diluents that are aries, not more than 5 percent. suitable and that are listed in part 73 4-Aminoazobenzene, not more than 50 parts of this chapter as safe for use in color per billion. additive mixtures for coloring drugs. 4-Aminobiphenyl, not more than 15 parts per (b) Specifications. (1) The color addi- billion. Aniline, not more than 250 parts per billion. tive FD&C Blue No. 1 for use in color- Azobenzene, not more than 200 parts per bil- ing drugs generally shall conform in lion. specifications to the requirements of Benzidine, not more than 1 part per billion. § 74.101(b).
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(2) FD&C Blue No. 1 Aluminum Lake Lower sulfonated subsidiary colors, not more shall be prepared in accordance with than 5 percent. the requirements of § 82.51 of this chap- Lead (as Pb), not more than 10 parts per mil- ter. lion. Arsenic (as As), not more than 3 parts per (c) Uses and restrictions. (1) FD&C million. Blue No. 1 may be safely used for color- Total color, not less than 85 percent. ing drugs, including drugs intended for (2) The color additive FD&C Blue No. use in the area of the eye, in amounts 2 for use in coloring ingested drugs consistent with current good manufac- shall conform to the specifications in turing practice. § 74.102(b). (2) FD&C Blue No. 1 Aluminum Lake (c) Uses and restrictions. (1) The color may be safely used for coloring drugs additive FD&C Blue No. 2 may be safe- intended for use in the area of the eye, ly used for coloring nylon (the copoly- in amounts consistent with current mer of adipic acid and hexamethylene good manufacturing practice, subject diamine) surgical sutures for use in to the restrictions on the use of color general surgery subject to the fol- additives in § 70.5(b) and (c) of this lowing restrictions: chapter. (i) The quantity of color additive (d) Labeling. The label of the color ad- does not exceed 1 percent by weight of ditive and any mixtures prepared the suture. therefrom intended solely or in part for (ii) The dyed suture shall conform in coloring purposes shall conform to the all respects to the requirements of the requirements of § 70.25 of this chapter. United States Pharmacopeia XX (1980). (e) Certification. All batches of FD&C (iii) When the sutures are used for Blue No. 1 shall be certified in accord- the purposes specified in their labeling, ance with regulations in part 80 of this the color additive does not migrate to chapter. the surrounding tissues. [47 FR 42565, Sept. 28, 1982, as amended at 59 (iv) If the suture is a new drug, an ap- FR 7638, Feb. 16, 1994] proved new drug application, pursuant to section 505 of the Federal Food, § 74.1102 FD&C Blue No. 2. Drug, and Cosmetic Act, is in effect for (a) Identity. (1) The color additive it. FD&C Blue No. 2 shall conform in iden- (2) The color additive FD&C Blue No. tity to the requirements of 2 may be safely used for coloring in- § 74.102(a)(1). gested drugs in amounts consistent (2) Color additive mixtures for use in with current good manufacturing prac- ingested drugs made with FD&C Blue tice. No. 2 may contain only those diluents (d) Labeling. The label of the color ad- that are suitable and that are listed in ditive and any mixtures prepared part 73 of this chapter as safe for use in therefrom intended solely or in part for color additive mixtures for coloring coloring purposes shall conform to the drugs. requirements of § 70.25 of this chapter. (e) Certification. All batches of FD&C (b) Specifications. (1) The color addi- Blue No. 2 shall be certified in accord- tive FD&C Blue No. 2 for use in color- ance with regulations in part 80 of this ing surgical sutures shall conform to chapter. the following specifications and shall be free from impurities other than [48 FR 5260, Feb. 4, 1983, as amended at 49 FR those named to the extent that such 10090, Mar. 19, 1984] impurities may be avoided by current good manufacturing practice: § 74.1104 D&C Blue No. 4. (a) Identity. (1) The color additive ° ° Sum of volatile matter at 135 C (275 F) and D&C Blue No. 4 is principally the chlorides and sulfates (calculated as so- dium salts), not more than 15 percent. diammonium salt of ethyl[4-[p[ethyl(m- α Water insoluble matter, not more than 0.4 sulfobenzyl)ami-no]- -(o- percent. sulfophenyl)benzylidene]-2,5-cyclo- Isatin-5-sulfonic acid, not more than 0.4 per- hexadien-1-ylidene] (m- sulfobenzyl) cent. ammonium hydroxide inner salt with Isomeric colors, not more than 18 percent. smaller amounts of the isomeric
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diammonium salts of ethyl [4-[p- § 74.1109 D&C Blue No. 9. [ethyl( sulfobenzyl) amino]-α-( p- o- (a) Identity. The color additive D&C sulfophenyl) benzylidene]-2,5- Blue No. 9 is principally 7,16-dichloro- cyclohexadien - 1-ylidene](p- 6,15 - dihydro - 5,9,14,18 - anthrazine- sulfobenzyl) ammonium hydroxide tetrone. inner salt and ethyl[4-[p-[ethyl (o- (b) Specifications. D&C Blue No. 9 sulfobenzyl)amino]-α-(o- sulfophenyl) shall conform to the following speci- benzylidene]-2,5-cyclohexadien-1- fications and shall be free from impuri- ylidene] (o- sulfobenzyl) ammonium ties other than those named to the ex- hydroxide inner salt. tent that such impurities may be (2) Color additive mixtures for use in avoided by good manufacturing prac- externally applied drugs made with tice: D&C Blue No. 4 may contain only those Volatile matter (at 135 °C.), not more than 3 diluents that are suitable and that are percent. listed in part 73 of this chapter for use Matter extractable by alcoholic HCl (0.1 ml in color additive mixtures for coloring of concentrated hydrochloric acid per 50 ml externally applied drugs. of 95 percent ethyl alcohol), not more than (b) Specifications. D&C Blue No. 4 1 percent. shall conform to the following speci- 2-Amino anthraquinone, not more than 0.2 percent. fications and shall be free from impuri- Organically combined chlorine in pure dye, ties other than those named to the ex- 13.0–14.8 percent. tent that such impurities may be Lead (as Pb), not more than 20 p/m. avoided by good manufacturing prac- Arsenic (as As), not more than 3 p/m. tice: Total color, not less than 97 percent. Sum of volatile matter (at 135 °C) and (c) Uses and restrictions. D&C Blue No. chlorides and sulfates (calculated as so- 9 may be safely used for coloring cot- dium salts), not more than 15 percent. ton and silk surgical sutures, including Water-insoluble matter, not more than 0.2 sutures for ophthalmic use, subject to percent. the following restrictions: Leuco base, not more than 5 percent. (1) The dyed suture shall conform in Sum of o-, m, and p- sulfobenzaldehydes, am- all respects to the requirements of the monium salt, not more than 1.5 percent. United States Pharmacopeia XX (1980). N-ethyl, N-(m- sulfobenzyl) sulfanilic acid (2) The quantity of the color additive ammonium salt, not more than 0.3 percent. does not exceed 2.5 percent by weight Subsidiary colors, not more than 6 percent. of the suture. Chromium (as Cr), not more than 50 parts (3) When the sutures are used for the per million. purposes specified in their labeling, the Lead (as Pb), not more than 20 parts per mil- color additive does not migrate to the lion. surrounding tissue. Arsenic (as As), not more than 3 parts per (4) If the suture is a new drug, a new- million. drug application approved pursuant to Mercury (as Hg), not more than 1 part per million. section 505 of the act is in effect for it. Total color, not less than 85 percent. (d) Labeling. The label of the color ad- ditive shall conform to the require- (c) Uses and restrictions. D&C Blue No. ments of § 70.25 of this chapter. 4 may be safely used in externally ap- (e) Certification. All batches of D&C plied drugs in amounts consistent with Blue No. 9 shall be certified in accord- good manufacturing practice. ance with regulations in part 80 of this (d) Labeling. The label of the color ad- chapter. ditive and any mixtures prepared [42 FR 15654, Mar. 22, 1977, as amended at 49 therefrom intended solely or in part for FR 10090, Mar. 19, 1984; 58 FR 17098, Apr. 1, coloring purposes shall conform to the 1993] requirements of § 70.25 of this chapter. (e) Certification. All batches of D&C § 74.1203 FD&C Green No. 3. Blue No. 4 shall be certified in accord- (a) Identity and specifications. (1) The ance with regulations in part 80 of this color additive FD&C Green No. 3 shall chapter. conform in identity and specifications
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to the requirements of § 74.203(a)(1) and Arsenic (as As), not more than 3 parts per (b). million. (2) Color additive mixtures for drug Total color, not less than 80 percent. use made with FD&C Green No. 3 may (2) D&C Green No. 5 for use in color- contain only those diluents that are ing drugs shall conform to the fol- suitable and that are listed in part 73 lowing specifications and shall be free of this chapter as safe for use in color from impurities other than those additive mixtures for coloring drugs. named to the extent that such other (b) Uses and restrictions. The color ad- impurities may be avoided by current ditive FD&C Green No. 3 may be safely good manufacturing practice: used for coloring drugs generally in amounts consistent with current good Sum of volatile matter (at 135 °C) and manufacturing practice. chlorides and sulfates (calculated as so- dium salts), not more than 20 percent. (c) Labeling. The label of the color ad- Water-insoluble matter, not more than 0.2 ditive and any mixtures prepared percent. therefrom intended solely or in part for 1,4-Dihydroxyanthraquinone, not more than coloring purposes shall conform to the 0.2 percent. requirements of § 70.25 of this chapter. Sulfonated toluidines, total not more than (d) Certification. All batches of FD&C 0.2 percent. Green No. 3 shall be certified in accord- p-Toluidine, not more than 0.0015 percent. ance with regulations in part 80 of this Sum of monosulfonated D&C Green No. 6 and chapter. Ext. D&C Violet No. 2, not more than 3 per- cent. [47 FR 52144, Nov. 19, 1982] Lead (as Pb), not more than 20 parts per mil- lion. § 74.1205 D&C Green No. 5. Arsenic (as As), not more than 3 parts per (a) Identity. (1) The color additive million. D&C Green No. 5 is principally the di- Mercury (as Hg), not more than 1 part per sodium salt of 2,2′-[(9,10-dihydro-9,10- million. dioxo-1,4-anthracenediyl)diimino]bis- Total color, not less than 80 percent. [5-methylbenzenesulfonic acid] (CAS (c) Use and restrictions. (1) D&C Green Reg. No. 4403–90–1). No. 5 may be safely used to color nylon (2) Color additive mixtures for use in 66 (the copolymer of adipic acid and drugs made with D&C Green No. 5 may hexamethylenediamine) and/or nylon contain only those diluents that are 6[poly-(e-caprolactam)]nonabsorbable suitable and those that are listed in surgical sutures for use in general sur- part 73 of this chapter for use in color gery, subject to the following restric- additive mixtures for coloring drugs. tions: (b) Specifications. (1) D&C Green No. 5 (i) The quantity of color additive for use in coloring surgical sutures does not exceed 0.6 percent by weight shall conform to the following speci- of the suture. fications and shall be free from impuri- (ii) When the sutures are used for the ties other than those named to the ex- purposes specified in their labeling, tent that such impurities may be there is no migration of the color addi- avoided by current good manufacturing tive to the surrounding tissue. practice: (iii) If the suture is a new drug, an Sum of volatile matter (at 135 °C) and approved new drug application, under chlorides and sulfates (calculated as so- section 505 of the act, is in effect for it. dium salts), not more than 20 percent. (2) D&C Green No. 5 may be safely Water insoluble matter, not more than 0.2 used for coloring drugs generally, in- percent. cluding drugs intended for use in the 1,4-Dihydroxyanthraquinone, not more than area of the eye, in amounts consistent 0.2 percent. with current good manufacturing prac- 2-Amino-m-toluenesulfonic acid, not more than 0.2 percent. tice. Subsidiary colors, not more than 5 percent. (d) Labeling. The label of the color ad- Lead (as Pb), not more than 10 parts per mil- ditive shall conform to the require- lion. ments of § 70.25 of this chapter.
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(e) Certification. All batches of D&C sodium salt of 8-hydroxy-1,3,6-pyrene- Green No. 5 shall be certified in accord- trisulfonic acid. ance with regulations in part 80 of this (2) Color additive mixtures for use in chapter. externally applied drugs made with [47 FR 24284, June 4, 1982; 47 FR 27551, June D&C Green No. 8 may contain only 25, 1982, as amended at 59 FR 40805, Aug. 10, those diluents that are suitable and 1994] that are listed in part 73 of this chapter for use in color additive mixtures for § 74.1206 D&C Green No. 6. coloring externally applied drugs. (a) Identity. The color additive D&C (b) Specifications. D&C Green No. 8 Green No. 6 is 1,4-bis[(4- shall conform to the following speci- methylphenyl)amino]-9,10- fications and shall be free from impuri- anthracenedione (CAS. Reg. No. 128–80– ties other than those named to the ex- 3). tent that such impurities may be (b) Specifications. The color additive avoided by good manufacturing prac- D&C Green No. 6 for use in coloring ex- tices: ternally applied drugs shall conform to Volatile matter (at 135 °C), not more than 15 the following specifications and shall percent. be free from impurities other than Water-insoluble matter, not more than 0.2 those named to the extent that such percent. other impurities may be avoided by Chlorides and sulfates (calculated as sodium current good manufacturing practice: salt), not more than 20 percent. The trisodium salt of 1,3,6-pyrenetrisulfonic Volatile matter (at 135 °C), not more than 2.0 acid, not more than 6 percent. percent. The tetrasodium salt of 1,3,6,8- Water-soluble matter, not more than 0.3 per- pyrenetetrasulfonic acid, not more than 1 cent. percent. Matter insoluble in carbon tetrachloride, not Pyrene, not more than 0.2 percent. more than 1.5 percent. Lead (as Pb), not more than 20 parts per mil- p-Toluidine, not more than 0.1 percent. lion. 1,4-Dihydroxyanthraquinone, not more than Arsenic (as As), not more than 3 parts per 0.2 percent. million. 1-Hydroxy-4-[(4-methylphenyl)amino]-9, 10- Mercury (as Hg), not more than 1 part per anthracenedione, not more than 5.0 per- million. cent. Total color, not less than 65 percent. Lead (as Pb), not more than 20 parts per mil- lion. (c) Uses and restrictions. D&C Green Arsenic (as As), not more than 3 parts per No. 8 may be safely used in externally million. applied drugs in amounts not exceeding Mercury (as Hg), not more than 1 part per 0.01 percent by weight of the finished million. product. Total color, not less than 96.0 percent. (d) Labeling. The label of the color ad- (c) Uses and restrictions. The color ad- ditive and any mixtures prepared ditive D&C Green No. 6 may be safely therefrom intended solely or in part for used for coloring externally applied coloring purposes shall conform to the drugs in amounts consistent with cur- requirements of § 70.25 of this chapter. rent good manufacturing practice. (e) Certification. All batches of D&C (d) Labeling. The label of the color ad- Green No. 8 shall be certified in accord- ditive shall conform to the require- ance with regulations in part 80 of this ments of § 70.25 of this chapter. chapter. (e) Certification. All batches of D&C Green No. 6 shall be certified in accord- § 74.1254 D&C Orange No. 4. ance with regulations promulgated (a) Identity. (1) the color additive under part 80 of this chapter. D&C Orange No. 4 is principally the so- [42 FR 15654, Mar. 22, 1977, as amended at 47 dium salt of 4-[(2-hydroxy-1- FR 14146, Apr.2, 1982; 47 FR 24278, June 4, naphthalenyl)azo]benzenesulfonic acid. 1982; 51 FR 9784, Mar. 21, 1986] (2) Color additive mixtures for use in externally applied drugs made with § 74.1208 D&C Green No. 8. D&C Orange No. 4 may contain only (a) Identity. (1) The color additive those diluents that are suitable and D&C Green No. 8 is principally the tri- that are listed in part 73 of this chapter
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for use in color additive mixtures for is isolated and partially purified prior coloring externally applied drugs. to bromination. (b) Specifications. D&C Orange No. 4 (2) Color additive mixtures for drug shall conform to the following speci- use made with D&C Orange No. 5 may fications and shall be free from impuri- contain only those diluents that are ties other than those named to the ex- suitable and that are listed in part 73 tent that such impurities may be of this chapter for use in color additive avoided by good manufacturing prac- mixtures for coloring drugs. tice. (b) Specifications. D&C Orange No. 5 Sum of volatile matter (at 135 °C) and shall conform to the following speci- chlorides and sulfates (calculated as so- fications and shall be free from impuri- dium salts), not more than 13 percent. ties other than those named to the ex- Water-insoluble matter, not more than 0.2 tent that such impurities may be percent. 2-Naphthol, not more than 0.4 percent. avoided by good manufacturing prac- Sulfanilic acid, sodium salt, not more than tice. 0.2 percent. 4′,5′-dibromofluorescein, not less than 50 per- Subsidiary colors, not more than 3 percent. cent and not more than 65 percent. 4,4′-(Diazoamino)-dibenzenesulfonic acid, not 2′,4′,5′-tribromofluorescein, not less than 30 more than 0.1 percent. percent and not more than 40 percent. Lead (as Pb), not more than 20 parts per mil- 2′,4′,5′,7′-tetrabromofluorescein, not more lion. than 10 percent. Arsenic (as As), not more than 3 parts per ′ ′ ′ ′ million. Sum of 2 ,4 -dibromofluorescein and 2 ,5 - Mercury (as Hg), not more than 1 part per dibromofluorescein, not more than 2 per- million. cent. Total color, not less than 87 percent. 4′–Bromofluorescein, not more than 2 per- cent. (c) Uses and restrictions. D&C Orange Fluorescein, not more than 1 percent. No. 4 may be safely used for coloring Phthalic acid, not more than 1 percent. externally applied drugs in amounts 2-(3,5-Dibromo-2,4-dihydroxybenzoyl) benzoic consistent with good manufacturing acid, not more than 0.5 percent. practice. Brominated resorcinol, not more than 0.4 (d) Labeling. The label of the color ad- percent. ditive and any mixtures prepared Sum of volatile matter (at 135 °C) and halides therefrom intended solely or in part for and sulfates (calculated as sodium salts), coloring purposes shall conform to the not more than 10 percent. requirements of § 70.25 of this chapter. Insoluble matter (alkaline solution), not (e) Certification. All batches of D&C more than 0.3 percent. Orange No. 4 shall be certified in ac- Lead (as Pb), not more than 20 parts per mil- cordance with regulations in part 80 of lion. this chapter. Arsenic (as As), not more than 3 parts per million. [42 FR 52396, Sept. 30, 1977, as amended at 43 Mercury (as Hg), not more than 1 part per FR 14642, Apr. 7, 1978; 46 FR 8461, Jan. 27, million. 1981] Total color, not less than 90 percent. § 74.1255 D&C Orange No. 5. (c) Uses and restrictions. D&C Orange No. 5 may be safely used for coloring (a) Identity. (1) the color additive D&C Orange No. 5 is a mixture con- mouthwashes and dentifrices that are sisting principally the sodium salt of ingested drugs in amounts consistent 4′,5′-dibromofluorescein (CAS Reg. No. with current good manufacturing prac- 596–03–2) and 2′,4′,5′-tribromofluorescein tice. D&C Orange No. 5 may be safely (CAS Reg. No. 25709–83–5) and 2′,4′,5′,7′- used in externally applied drugs in tetrabromofluorescein (CAS Reg. No. amounts not exceeding 5 milligrams 15086–94–9). D&C Orange No. 5 is manu- per daily dose of the drug. factured by brominating fluorescein (d) Labeling. The label of the color ad- with elemental bromine. The fluores- ditive and any mixtures prepared cein is manufactured by the acid con- therefrom intended solely or in part for densation of resorcinol and phthalic coloring purposes shall conform to the acid or its anhydride. The fluorescein requirements of § 70.25 of this chapter.
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(e) Certification. All batches of D&C form to the requirements of § 70.25 of Orange No. 5 shall be certified in ac- this chapter. cordance with regulations in part 80 of (e) Certification. All batches of D&C this chapter. Orange No. 10 shall be certified in ac- [47 FR 44635, Nov. 2, 1982, as amended at 49 cordance with regulations in part 80 of FR 13342, Apr. 4, 1984] this chapter. [46 FR 18953, Mar. 27, 1981] § 74.1260 D&C Orange No. 10. (a) Identity. (1) The color additive § 74.1261 D&C Orange No. 11. D&C Orange No. 10 is a mixture con- (a) Identity. (1) The color additive ′ ′ sisting principally of 4 ,5 - D&C Orange No. 11 is a mixture con- ′ ′ ′ diiodofluorescein, 2 ,4 ,5 - sisting principally of the disodium ′ ′ ′ ′ triiodofluorescein, and 2 ,4 ,5 ,7 - salts of 4′,5′-diiodofluorescein, 2′,4′,5′- tetraiodofluorescein. triiodofluorescein and 2′,4′,5′,7′- (2) Color additive mixtures for drug tetraiodofluorescein. use made with D&C Orange No. 10 may (2) Color additive mixtures for drug contain only those diluents listed in use made with D&C Orange No. 11 may this subpart as safe and suitable for use contain only those diluents listed in in color additive mixtures for coloring this subpart as safe and suitable for use externally applied drugs. in color additive mixtures for coloring (b) Specifications. D&C Orange No. 10 shall conform to the following speci- externally applied drugs. fications and shall be free from impuri- (b) Specifications. The color additive ties other than those named to the ex- D&C Orange No. 11 shall conform to tent that such other impurities may be the following specifications and shall avoided by good manufacturing prac- be free from impurities other than tice: those named to the extent that such impurities may be avoided by good Sum of volatile matter (at 135 °C) and halides manufacturing practice: and sulfates (calculated as sodium salts), not more than 8 percent. Sum of volatile matter (at 135 °C) and halides Insoluble matter (alkaline solution), not and sulfates (calculated as sodium salts), more than 0.5 percent. not more than 8 percent. Phthalic acid, not more than 0.5 percent. Water-insoluble matter, not more than 0.5 2-[3′,5′-Diiodo-2′,4′-dihydroxybenzoyl] benzoic percent. acid, not more than 0.5 percent. Phthalic acid, not more than 0.5 percent. Fluorescein, not more than 1 percent. 2-[3′,5′-Diiodo-2′,4′-dihydroxybenzoyl] benzoic 4′-Iodofluorescein, not more than 3 percent. acid, sodium salt, not more than 0.5 per- 2′,4′-Diiodofluorescein and 2′,5′- cent. diiodofluorescein, not more than 2 percent. Fluorescein, disodium salt, not more than 1 2′,4′,5′-Triiodofluorescein, not more than 35 percent. percent. 4′-Iodofluorescein, disodium salt, not more 2′,4′,5′,7′-Tetraiodofluorescein, not more than than 3 percent. 10 percent. 2′,4′-Diiodofluorescein and 2′,5′- ′ ′ 4 ,5 -Diiodofluorescein, not less than 60 per- diiodofluorescein, not more than 2 percent. cent and not more than 95 percent. 2′,4′,5′-Triiodofluorescein, not more than 35 Lead (as Pb), not more than 20 parts per mil- percent. lion. 2′,4′,5′,7′-Tetraiodofluorescein, disodium salt, Arsenic (as As), not more than 3 parts per not more than 10 percent. million. 4′,5′-Diiodofluorescein, disodium salt, not Mercury (as Hg), not more than 1 part per less than 60 percent and not more than 95 million. percent. Total color, not less than 92 percent. Lead (as Pb), not more than 20 parts per mil- (c) Uses and restrictions. D&C Orange lion. No. 10 may be safely used for coloring Arsenic (as As), not more than 3 parts per externally applied drugs in amounts million. consistent with good manufacturing Mercury (as Hg), not more than 1 part per practice. million. (d) Labeling requirements. The label of Total color, not less than 92 percent. the color additive and any mixtures (c) Uses and restrictions. D&C Orange prepared therefrom intended solely or No. 11 may be safely used for coloring in part for coloring purposes shall con- externally applied drugs in amounts
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consistent with good manufacturing avoided by good manufacturing prac- practice. tice: (d) Labeling requirements. The label of ° the color additive and any mixtures Sum of volatile matter (at 135 C.) and chlorides and sulfates (calculated as so- prepared therefrom intended solely or dium salts), not more than 13 percent. in part for coloring purposes shall con- Water-insoluble matter, not more than 0.2 form to the requirements of § 70.25 of percent. this chapter. 5-Amino-2,4-dimethyl-1-benzenesulfonic acid, (e) Certification. All batches of D&C sodium salt, not more than 0.2 percent. Orange No. 11 shall be certified in ac- 4-Hydroxy-1-naphthalenesulfonic acid, so- cordance with regulations in part 80 of dium salt, not more than 0.2 percent. this chapter. Subsidiary colors, not more than 2 percent. [46 FR 18953, Mar. 27, 1981] Lead (as Pb), not more than 10 parts per mil- lion. § 74.1303 FD&C Red No. 3. Arsenic (as As), not more than 3 parts per million. (a) Identity and specifications. (1) The Mercury (as Hg), not more than 1 part per color additive FD&C Red No. 3 shall million. conform in identity and specifications Total color, not less than 87 percent. to the requirements of § 74.303(a)(1) and (b). (c) Uses and restrictions. FD&C Red (2) Color additive mixtures for in- No. 4 may be safely used in externally gested drug used made with FD&C Red applied drugs in amounts consistent No. 3 may contain only those diluents with good manufacturing practice. that are suitable and that are listed in (d) Labeling. The label of the color ad- part 73 of this chapter as safe for use in ditive and any mixtures prepared color additive mixtures for coloring in- therefrom intended solely or in part for gested drugs. coloring purposes shall conform to the (b) Uses and restrictions. FD&C Red requirements of § 70.25 of this chapter. No. 3 may be safely used for coloring (e) Certification. All batches of FD&C ingested drugs in amounts consistent Red No. 4 shall be certified in accord- with good manufacturing practice. ance with regulations in part 80 of this (c) Labeling. The label of the color ad- chapter. ditive and any mixtures prepared therefrom intended solely or in part for § 74.1306 D&C Red No. 6. coloring purposes shall conform to the requirements of § 70.25 of this chapter. (a) Identity. (1) The color additive (d) Certification. All batches of FD&C D&C Red No. 6 is principally the diso- Red No. 3 shall be certified in accord- dium salt of 3-hydroxy-4-[(4-methyl-2- ance with regulations in part 80 of this sulfophenyl)azo]-2- chapter. naphthalenecarboxylic acid (CAS Reg. No. 5858–81–1). To manufacture the ad- § 74.1304 FD&C Red No. 4. ditive, 2-amino-5- (a) Identity. (1) The color additive methylbenzenesulfonic acid is FD&C Red No. 4 is principally the diso- diazotized with hydrochloric acid and dium salt of 3-[(2,4-dimethyl-5- sodium nitrite. The diazo compound is sulfophenyl)azo] -4-hydroxy-1- coupled in alkaline medium with 3-hy- naphthalenesulfonic acid. droxy-2-naphthalenecarboxylic acid. (2) Color additive mixtures for use in The resulting dye precipitates as the externally applied drugs made with disodium salt. FD&C Red No. 4 may contain only (2) Color additive mixtures for drug those diluents that are suitable and use made with D&C Red No. 6 may con- that are listed in part 73 of this chapter tain only those diluents that are suit- for use in color additive mixtures for able and that are listed in part 73 of coloring externally applied drugs. this chapter as safe for use in color ad- (b) Specifications. FD&C Red No. 4 ditive mixtures for coloring drugs. shall conform to the following speci- (b) Specifications. The color additive fications and shall be free from impuri- D&C Red No. 6 shall conform to the fol- ties other than those named to the ex- lowing specifications and shall be free tent that such impurities may be from impurities other than those
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named to the extent that such impuri- tain only those diluents that are suit- ties may be avoided by current good able and that are listed in part 73 of manufacturing practice: this chapter as safe for use in color ad- ditive mixtures for coloring drugs. Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as so- (b) Specifications. The color additive dium salts), not more than 10 percent. D&C Red No. 7 shall conform to the fol- Ether-soluble matter, passes test entitled lowing specifications and shall be free ‘‘The Procedure for Determining Ether- from impurities other than those Soluble Material in D&C Red Nos. 6 and 7,’’ named to the extent that such impuri- which is an Appendix A to part 74. ties may be avoided by current good 2-Amino-5-methylbenzenesulfonic acid, so- manufacturing practice: dium salt, not more than 0.2 percent. 3-Hydroxy-2-naphthalenecarboxylic acid, so- Sum of volatile matter (at 135 °C) and dium salt, not more than 0.4 percent. chlorides and sulfates (calculated as so- 3-Hydroxy-4-[(4-methylphenyl)azo]-2- dium salts), not more than 10 percent. naphthalenecarboxylic acid, sodium salt, Ether-soluble matter, passes test entitled not more than 0.5 percent. ‘‘The Procedure for Determining Ether- p- Toluidine, not more than 15 parts per mil- soluble Material in D&C Red Nos. 6 and 7,’’ lion. which is an Appendix A to part 74. Lead (as Pb), not more than 20 parts per mil- 2-Amino-5-methylbenzenesulfonic acid, cal- lion. cium salt, not more than 0.2 percent. Arsenic (as As), not more than 3 parts per 3-Hydroxy-2-naphthalenecarboxylic acid, cal- million. cium salt, not more than 0.4 percent. Mercury (as Hg), not more than 1 part per 3-Hydroxy-4-[(4-methylphenyl)azo]-2- million. naphthalenecarboxylic acid, calcium salt, Total color, not less than 90 percent. not more than 0.5 percent. p-Toluidine, not more than 15 parts per mil- (c) Uses and restrictions. The color ad- lion. ditive D&C Red No. 6 may be safely Lead (as Pb), not more than 20 parts per mil- used for coloring drugs such that the lion. combined total of D&C Red No. 6 and Arsenic (as As), not more than 3 parts per D&C Red No. 7 does not exceed 5 milli- million. grams per daily dose of the drug. Mercury (as Hg), not more than 1 part per (d) Labeling. The label of the color ad- million. ditive and any mixtures prepared Total color, not less than 90 percent. therefrom intended solely or in part for (c) Uses and restrictions. The color ad- coloring purposes shall conform to the ditive D&C Red No. 7 may be safely requirements of § 70.25 of this chapter. used for coloring drugs such that the (e) Certification. All batches of D&C combined total of D&C Red No. 6 and Red No. 6 shall be certified in accord- D&C Red No. 7 does not exceed 5 milli- ance with regulations in part 80 of this grams per daily dose of the drug. chapter. (d) Labeling. The label of the color ad- ditive and any mixtures prepared [47 FR 57687, Dec. 28, 1982] therefrom intended solely or in part for § 74.1307 D&C Red No. 7. coloring purposes shall conform to the requirements of § 70.25 of this chapter. (a) (1) The color additive Identity. (e) Certification. All batches of D&C D&C Red No. 7 is principally the cal- Red No. 7 shall be certified in accord- cium salt of 3-hydroxy-4-[(4-methyl-2- ance with regulations in part 80 of this sulfophenyl)azo]-2- chapter. naphthalenecarboxylic acid (CAS Reg. No. 5281–04–9). To manufacture the ad- [47 FR 57687, Dec. 28, 1982] ditive, 2-amino-5- methylbenzenesulfonic acid is § 74.1317 D&C Red No. 17. diazotized with hydrochloric acid and (a) Identity. (1) The color additive sodium nitrite. The diazo compound is D&C Red No. 17 is principally 1-[[4- coupled in alkaline medium with 3-hy- (phenylazo)phenyl]azo]-2-naphthalenol. droxy-2-naphthalenecarboxylic acid (2) Color additive mixtures for drug and the resulting dye converted to the use made with D&C Red No. 17 may calcium salt with calcium chloride. contain only those diluents that are (2) Color additive mixtures for drug suitable and that are listed in part 73 use made with D&C Red No. 7 may con- of this chapter as safe for use in color
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additive mixtures for coloring exter- cein is manufactured by the acid con- nally applied drugs. densation of resorcinol and phthalic (b) Specifications. D&C Red No. 17 acid or its anhydride. The fluorescein shall conform to the following speci- is isolated and partially purified prior fications and shall be free from impuri- to bromination. ties, other than those named, to the ex- (2) Color additive mixtures for drug tent that such other impurities may be use made with D&C Red No. 21 may avoided by good manufacturing prac- contain only those diluents that are tice: suitable and that are listed in part 73 Volatile matter (at 135 °C), not more than 5 of this chapter as safe for use in color percent. additive mixtures for coloring drugs. Matter insoluble in both toluene and water (b) Specifications. The color additive (color additive mixed in toluene and the D&C Red No. 21 shall conform to the resultant residue isolated and mixed with following specifications and shall be water to obtain the matter insoluble in free from impurities other than those both toluene and water), not more than 0.5 percent. named to the extent that such impuri- Chlorides and sulfates (calculated as sodium ties may be avoided by current good salts), not more than 3 percent. manufacturing practice: Aniline, not more than 0.2 percent. 4-Aminoazobenzene, not more than 0.1 per- Sum of volatile matter (at 135°C) and halides cent. and sulfates (calculated as sodium salts), 2-Naphthol, not more than 0.2 percent. not more than 10 percent. 1-(Phenylazo)-2-naphthol, not more than 3 Insoluble matter (alkaline solution), not percent. more than 0.5 percent. 1-[[2-(phenylazo) phenyl]azo]-2-naphthalenol, Phthalic acid, not more than 1 percent. not more than 2 percent. 2-(3,5-Dibromo-2,4-dihydroxybenzoyl) benzoic Lead (as Pb), not more than 20 parts per mil- acid, not more than 0.5 percent. lion. 2′,4′,5′,7′-Tetrabromofluorescein, ethyl ester, Arsenic (as As), not more than 3 parts per not more than 1 percent. million. Brominated resorcinol, not more than 0.4 Mercury (as Hg), not more than 1 part per percent. million. Fluorescein, not more than 0.2 percent. Total color, not less than 90 percent. Sum of mono- and dibromofluoresceins, not (c) Uses and restrictions. D&C Red No. more than 2 percent. 17 may be safely used in externally ap- Tribromofluoresceins, not more than 11 per- plied drugs in amounts consistent with cent. good manufacturing practice. 2′,4′,5′,7′-Tetrabromofluorescein, not less (d) Labeling. The label of the color ad- than 87 percent. ditive and any mixtures prepared Lead (as Pb), not more than 20 parts per mil- therefrom intended solely or in part for lion. Arsenic (as As), not more than 3 parts per coloring purposes shall conform to the million. requirements of § 70.25 of this chapter. Mercury (as Hg), not more than 1 part per (e) Certification. All batches of D&C million. Red No. 17 shall be certified in accord- Total color, not less than 90 percent. ance with regulations in part 80 of this chapter. (c) Uses and restrictions. The color ad- ditive D&C Red No. 21 may be safely [42 FR 15654, Mar. 22, 1977, as amended at 42 used for coloring drugs generally in FR 27225, May 27, 1977] amounts consistent with current good § 74.1321 D&C Red No. 21. manufacturing practice. (d) Labeling. The label of the color ad- (a) Identity. (1) The color additive ditive and any mixtures prepared ′ ′ ′ ′ D&C Red No. 21 is principally 2 ,4 ,5 ,7 - therefrom intended solely or in part for tetrabromofluorescein (CAS Reg. No. coloring purposes shall conform to the 15086–94–9), and may contain smaller requirements of § 70.25 of this chapter. amounts of 2′,4′,5′-tribromofluorescein (e) Certification. All batches of D&C (CAS Reg. No. 25709–83–5) and 2′,4′,7′ ¥ Red No. 21 shall be certified in accord- tribromofluorescein (CAS Reg. No. ance with regulations in part 80 of this 25709–84–6). The color additive is manu- chapter. factured by brominating fluorescein with elemental bromine. The fluores- [47 FR 53846, Nov. 30, 1982]
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§ 74.1322 D&C Red No. 22. (c) Uses and restrictions. The color ad- (a) Identity. (1) The color additive ditive D&C Red No. 22 may be safely D&C Red No. 22 is principally the diso- used for coloring drugs generally in dium salt of 2′,4′,5′7′- amounts consistent with current good tetrabromofluorescein (CAS Reg. No. manufacturing practice. 17372–87–1) and may contain smaller (d) Labeling. The label of the color ad- amounts of the disodium salts of 2′,4′,5′- ditive and any mixtures prepared tribromofluorescein and 2′,4′,7′- therefrom intended solely or in part for tribromofluorescein. The color additive coloring purposes shall conform to the is manufactured by alkaline hydrolysis requirements of § 70.25 of this chapter. of 2′,4′,5′,7′-tetrabromofluorescein. (e) Certification. All batches of D&C 2′,4′,5′,7′-Tetrabromofluorescein is man- Red No. 22 shall be certified in accord- ufactured by brominating fluorescein ance with regulations in part 80 of this with elemental bromine. The fluores- chapter. cein is manufactured by the acid con- [47 FR 53846, Nov. 30, 1982] densation of resorcinol and phthalic acid or its anhydride. Fluorescein is § 74.1327 D&C Red No. 27. isolated and partially purified prior to (a) Identity. (1) The color additive bromination. ′ ′ ′ ′ (2) Color additive mixtures for drug D&C Red No. 27 is principally 2 ,4 ,5 ,7 - use made with Red No. 22 may contain tetrabromo-4,5,6,7- only those diluents that are suitable tetrachlorofluorescein (CAS Reg. No. and that are listed in part 73 of this 13473-26-2). The color additive is manu- chapter as safe for use in color additive factured by brominating 4,5,6,7- mixtures for coloring drugs. tetrachlorofluorescein with elemental (b) Specifications. The color additive bromine. The 4,5,6,7- D&C Red No. 22 shall conform to the tetrachlorofluorescein is manufactured following specifications and shall be by the acid condensation of resorcinol free from impurities other than those and tetrachlorophthalic acid or its an- named to the extent that such impuri- hydride. The 4,5,6,7- ties may be avoided by current good tetrachlorofluorescein is isolated and manufacturing practice: partially purified prior to bromination. (2) Color additive mixtures for drug Sum of volatile matter (at 135°C) and halides use made with D&C Red No. 27 may and sulfates (calculated as soduim salts), contain only those diluents that are not more than 10 percent. Water-insoluble matter not more than 0.5 suitable and that are listed in part 73 percent. of this chapter as safe for use in color Disodium salt of phthalic acid, not more additive mixtures for coloring drugs. than 1 percent. (b) Specifications. D&C Red No. 27 Sodium salt of 2-(3,5-Dibromo-2,4- shall conform to the following speci- dihydroxybenzoyl)benzoic acid, not more fications and shall be free from impuri- than 0.5 percent. ties other than those named to the ex- 2′,4′,5′,7′-Tetrabromofluorescein, ethyl ester, not more than 1 percent. tent that such impurities may be Brominated resorcinol, not more than 0.4 avoided by current good manufacturing percent. practice: Sum of disodium salts of mono- and ° dibromofluoresceins, not more than 2 per- Sum of volatile matter (at 135 C) and halides cent. and sulfates (calculated as sodium salts), Sum of disodium salts of not more than 10 percent. tribromofluoresceins, not more than 25 Insoluble matter (alkaline solution), not percent. more than 0.5 percent. Disodium salt of 2′,4′,5′,7′- Tetrachlorophthalic acid, not more than 1.2 Tetrabromofluorescein, not less than 72 percent. percent. Brominated resorcinol, not more than 0.4 Lead (as Pb), not more than 20 parts per mil- percent. lion. 2,3,4,5-Tetrachloro-6-(3,5-dibromo-2,4- Arsenic (as As), not more than 3 parts per dihydroxybenzoyl) benzoic acid, not more million. than 0.7 percent. Mercury (as Hg), not more than 1 part per 2′,4′,5′,7′-Tetrabromo-4,5,6,7- million. tetrachlorofluorescein, ethyl ester, not Total color, not less than 90 percent. more than 2 percent.
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Lower halogenated subsidiary colors, not 2′,4′,5′,7′-Tetrabromo-4,5,6,7- more than 4 percent. tetrachlorofluorescein, ethyl ester, not Lead (as Pb), not more than 20 parts per mil- more than 2 percent. lion. Lower halogenated subsidiary colors, not Arsenic (as As), not more than 3 parts per more than 4 percent. million. Lead (as Pb), not more than 20 parts per mil- Mercury (as Hg), not more than 1 part per lion. million. Arsenic (as As), not more than 3 parts per Total color, not less than 90 percent. million. Mercury (as Hg), not more than 1 part per (c) Uses and restrictions. D&C Red No. million. 27 may be safely used for coloring Total color, not less than 85 percent. drugs generally in amounts consistent (c) Uses and restrictions. D&C Red No. with current good manufacturing prac- 28 may be safely used for coloring tice. drugs generally in amounts consistent (d) Labeling. The label of the color ad- with current good manufacturing prac- ditive and any mixtures prepared tice. therefrom intended solely or in part for (d) Labeling. The label of the color ad- coloring purposes shall conform to the ditive and any mixtures prepared requirements of § 70.25 of this chapter. therefrom intended solely or in part for (e) Certification. All batches of D&C coloring purposes shall conform to the Red No. 27 shall be certified in accord- requirements of § 70.25 of this chapter. ance with regulations in part 80 of this (e) Certification. All batches of D&C chapter. Red No. 28 shall be certified in accord- ance with regulations in part 80 of this [47 FR 42567, Sept. 28, 1982; 47 FR 51106, Nov. chapter. 12, 1982] [47 FR 42568, Sept. 28, 1982] § 74.1328 D&C Red No. 28. § 74.1330 D&C Red No. 30. (a) Identity. (1) The color additive D&C Red No. 28 is principally the diso- (a) Identity. (1) The color additive dium salt of 2′,4′,5′,7′-tetrabromo-4,5,6,7- D&C Red No. 30 is principally 6-chloro- tetrachlorofluorescein (CAS Reg. No. 2-(6-chloro-4-methyl-3- 18472–87–2) formed by alkaline hydrol- oxobenzo[b]thien-2(3H)-ylidene)-4- ysis of the parent methyl-benzo[b]thiophen-3(2H)-one tetrabromotetrachlorofluorescein. (CAS Reg. No. 2379–74–0). (2) Color additive mixtures for drug (2) Color additive mixtures for drug use made with D&C Red No. 28 may use made with D&C Red No. 30 may contain only those diluents that are contain only those diluents that are suitable and that are listed in part 73 suitable and that are listed in part 73 of this chapter as safe for use in color of this chapter as safe for use in color additive mixtures for coloring drugs. additive mixtures for coloring drugs. (b) Specifications. D&C Red No. 30 (b) Specifications. D&C Red No. 28 shall conform to the following speci- shall conform to the following speci- fications and shall be free from impuri- fications and shall be free from impuri- ties other than those named to the ex- ties other than those named to the ex- tent that such impurities may be tent that such impurities may be avoided by current good manufacturing avoided by current good manufacturing practice: practice: Volatile matter (at 135 °C), not more than 5 ° Sum of volatile matter (at 135 C) and halides percent. and sulfates (calculated as sodium salts), Chlorides and sulfates (calculated as sodium not more than 15 percent. salts), not more than 3 percent. Insoluble matter (alkaline solution), not Matter soluble in acetone, not more than 5 more than 0.5 percent. percent. Tetrachlorophthalic acid, not more than 1.2 Total color, not less than 90 percent. percent. Lead (as Pb), not more than 20 parts per mil- Brominated resorcinol, not more than 0.4 lion. percent. Arsenic (as As), not more than 3 parts per 2,3,4,5-Tetrachloro-6-(3,5-dibromo-2,4- million. dihydroxybenzoyl)benzoic acid, not more Mercury (as Hg), not more than 1 part per than 0.7 percent. million.
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(c) Uses and restrictions. D&C Red No. (e) Certification. All batches of D&C 30 may be safely used for coloring Red No. 31 shall be certified in accord- drugs generally in amounts consistent ance with regulations in part 80 of this with current good manufacturing prac- chapter. tice. (d) Labeling. The label of the color ad- § 74.1333 D&C Red No. 33. ditive and any mixtures prepared (a) Identity. (1) The color additive therefrom intended solely or in part for D&C Red No. 33 is principally the diso- coloring purposes shall conform to the dium salt of 5-amino-4-hydroxy-3- requirements of § 70.25 of this chapter. (phenylazo)-2,7-naphthalenedisulfonic (e) Certification. All batches of D&C acid (CAS Reg. No. 3567–66–6). To manu- Red No. 30 shall be certified in accord- facture the additive, the product ob- ance with regulations in part 80 of this tained from the nitrous acid chapter. diazotization of aniline is coupled with 4-hydroxy-5-amino-2,7- [47 FR 22510, May 25, 1982] naphthalenedisulfonic acid in an alka- § 74.1331 D&C Red No. 31. line aqueous medium. The color addi- tive is isolated as the sodium salt. (a) Identity. (1) The color additive (2) Color additive mixtures for drug D&C Red No. 31 is principally the cal- use made with D&C Red No. 33 may cium salt of 3-hydroxy-4-(phenylazo)-2- contain only those diluents that are naphthalenecarboxylic acid. suitable and that are listed in part 73 (2) Color additive mixtures for drug of this chapter as safe for use in color use made with D&C Red No. 31 may additive mixtures for coloring drugs. contain only those diluents that are (b) Specifications. D&C Red No. 33 suitable and that are listed in part 73 shall conform to the following speci- of this chapter as safe for use in color fications and shall be free from impuri- additive mixtures for coloring exter- ties other than those named to the ex- nally applied drugs. tent that such impurities may be (b) Specifications. D&C Red No. 31 avoided by current good manufacturing shall conform to the following speci- practices: fications and shall be free from impuri- ° ° ties, other than those named, to the ex- Sum of volatile matter at 135 C (275 F) and chlorides and sulfates (calculated as so- tent that such other impurities may be dium salts), not more than 18 percent. avoided by good manufacturing prac- Water-insoluble matter, not more than 0.3 tice: percent. 4-Amino-5-hydroxy-2,7-naphthalenedisulfonic Sum of volatile matter (at 135 °C) and acid, disodium salt, not more than 0.3 per- chlorides and sulfates (calculated as so- cent. dium salts), not more than 10 percent. 4,5-Dihydroxy-3-(phenylazo)-2,7- Aniline, not more than 0.2 percent. naphthalenedisulfonic acid, disodium salt, 3-Hydroxy-2-naphthoic acid, calcium salt, not more than 3.0 percent. not more than 0.4 percent. Aniline, not more than 25 parts per million. Subsidiary colors, not more than 1 percent. 4-Aminoazobenzene, not more than 100 parts Lead (as Pb), not more than 20 parts per mil- per billion. lion. 1,3-Diphenyltriazene, not more than 125 parts Arsenic (as As), not more than 3 parts per per billion. million. 4-Aminobiphenyl, not more than 275 parts Mercury (as Hg), not more than 1 part per per billion. million. Azobenzene, not more than 1 part per mil- Total color, not less than 90 percent. lion. Benzidine, not more than 20 parts per billion. (c) Uses and restrictions. D&C Red No. Lead (as Pb), not more than 20 parts per mil- 31 may be safely used in externally ap- lion. plied drugs in amounts consistent with Arsenic (as As), not more than 3 parts per good manufacturing practice. million. (d) Labeling. The label of the color ad- Mercury (as Hg), not more than 1 part per ditive and any mixtures prepared million. therefrom intended solely or in part for Total color, not less than 82 percent. coloring purposes shall conform to the (c) Uses and restrictions. The color ad- requirements of § 70.25 of this chapter. ditive D&C Red. No 33 may be safely
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used for coloring ingested drugs, other drugs in amounts consistent with good than mouthwashes and dentifrices, in manufacturing practice. amounts not to exceed 0.75 milligram (d) Labeling. The label of the color ad- per daily dose of the drug. D&C Red No. ditive and any mixtures prepared 33 may be safely used for coloring ex- therefrom intended solely or in part for ternally applied drugs, mouthwashes, coloring purposes shall conform to the and dentifrices in amounts consistent requirements of § 70.25 of this chapter. with current good manufacturing prac- (e) Certification. All batches of D&C tice. Red No. 34 shall be certified in accord- (d) Labeling requirements. The label of ance with regulations in part 80 of this the color additive and any mixtures chapter. prepared therefrom intended solely or in part for coloring purposes shall con- § 74.1336 D&C Red No. 36. form to the requirements of § 70.25 of (a) Identity. (1) The color additive this chapter. D&C Red No. 36 is 1-[(2-chloro-4- (e) Certification. All batches of D&C nitrophenyl)azo]-2-naphthalenol (CAS Red No. 33 shall be certified in accord- Reg. No. 2814–77–9). The color additive ance with regulations in part 80 of this is manufactured by diazotization of 2- chapter. chloro-4-nitrobenzenamine in acid me- dium and coupling with 2-naphthalenol [53 FR 33120, Aug. 30, 1988] in acid medium. § 74.1334 D&C Red No. 34. (2) Color additive mixtures for drug use made with D&C Red No. 36 may (a) Identity. (1) The color additive contain only those diluents that are D&C Red No. 34 is principally the cal- suitable and that are listed in part 73 cium salt of 3-hydroxy-4-[(1-sulfo-2- of this chapter as safe for use in color naphthalenyl)azo]-2-naphthalene-car- additive mixtures for coloring drugs. boxylic acid. (b) Specifications. D&C Red No. 36 (2) Color additive mixtures for drug shall conform to the following speci- use made with D&C Red No. 34 may fications and shall be free from impuri- contain only those diluents that are ties other than those named to the ex- suitable and that are listed in part 73 tent that such impurities may be of this chapter as safe for use in color avoided by current good manufacturing additive mixtures for coloring exter- practice: nally applied drugs. (b) Specifications. D&C Red No. 34 Volatile matter at 135 °C (275 °F), not more shall conform to the following speci- than 1.5 percent. fications and shall be free from impuri- Matter insoluble in toluene, not more than 1.5 percent. ties, other than those named, to the ex- 2-Chloro-4-nitrobenzenamine, not more than tent that such other impurities may be 0.3 percent. avoided by good manufacturing prac- 2-Naphthalenol, not more than 1 percent. tice: 2,4-Dinitrobenzenamine, not more than 0.02 percent. Sum of volatile matter (at 135 °C) and 1-[(2,4-Dinitrophenyl)azo]-2-naphthalenol, chlorides and sulfates (calculated at so- not more than 0.5 percent. dium salts), not more than 15 percent. 4-[(2-Chloro-4-nitrophenyl)azo]-1- 2-Amino-1-naphthalenesulfonic acid, calcium naphthalenol, not more than 0.5 percent. salt, not more than 0.2 percent. 1-[(4-Nitrophenyl)azo]-2-naphthalenol, not 3-Hydroxy-2-naphthoic acid, not more than more than 0.3 percent. 0.4 percent. 1-[(4-Chloro-2-nitrophenyl)azo]-2- Subsidiary colors, not more than 4 percent. naphthalenol, not more than 0.3 percent. Lead (as Pb), not more than 20 parts per mil- Lead (as Pb), not more than 20 parts per mil- lion. lion. Arsenic (as As), not more than 3 parts per Arsenic (as As), not more than 3 parts per million. million. Mercury (as Hg), not more than 1 part per Mercury (as Hg), not more than 1 part per million. million. Total color not less than 85 percent. Total color, not less than 95 percent. (c) Uses and restrictions. The color ad- (c) Uses and restrictions. The color ad- ditive D&C Red No. 34 may be safely ditive D&C Red No. 36 may be safely used for coloring externally applied used for coloring ingested drugs, other
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than mouthwashes and dentifrices, in used for the coloring of quaternary am- amounts not to exceed 1.7 milligrams monium type germicidal solutions in- per daily dose of the drug for drugs tended for external application only, that are taken continuously only for and subject to the further restriction less than 1 year. For drugs taken con- that the quantity of the color additive tinuously for longer than 1 year, the does not exceed 0.1 percent by weight color additive shall not be used in of the finished drug product. amounts to exceed 1.0 milligram per (d) Labeling. The label of the color ad- daily dose of the drug. D&C Red No. 36 ditive and any mixtures prepared may be safely used for coloring exter- therefrom and intended solely or in nally applied drugs in amounts con- part for coloring purposes shall con- sistent with current good manufac- form to the requirements of § 70.25 of turing practice. this chapter. (d) Labeling requirements. The label of (e) Certification. All batches of D&C the color additive and any mixtures Red No. 39 shall be certified in accord- prepared therefrom intended solely or ance with regulations promulgated in part for coloring purposes shall con- under part 80 of this chapter. form to the requirements of § 70.25 of this chapter. § 74.1340 FD&C Red No. 40. (e) Certification. All batches of D&C (a) Identity and specifications. (1) The Red No. 36 shall be certified in accord- color additive FD&C Red No. 40 shall ance with regulations in part 80 of this conform in identity and specifications chapter. to the requirements of § 74.340(a)(1) and (b). [53 FR 29031, Aug. 2, 1988; 53 FR 35255, Sept. 12, 1988, as amended at 53 FR 52130, Dec. 27, (2) Color additive mixtures for drug 1988] use made with FD&C Red No. 40 may contain only those diluents that are § 74.1339 D&C Red No. 39. suitable and that are listed in part 73 (a) Identity. (1) The color additive of this chapter as safe for use in color D&C Red No. 39 is o-[p(β,β′-dihydroxy- additive mixtures for coloring drugs. diethylamino)-phenylazo]-benzoic acid. (3) The listing of this color additive (2) Color additive mixtures made includes lakes prepared as described in with D&C Red No. 39 may contain the §§ 82.51 and 82.1051 of this chapter, ex- following diluents: Water, acetone, iso- cept that the color additive used is propyl alcohol, and specially denatured FD&C Red No. 40 and the resultant alcohols used in accordance with 26 lakes meet the specification and label- CFR part 212. ing requirements prescribed by §§ 82.51 (b) Specifications. D&C Red No. 39 or 82.1051 of this chapter.) shall conform to the following speci- (b) Uses and restrictions. (1) FD&C Red fications and shall be free from impuri- No. 40 and FD&C Red No. 40 Aluminum ties other than those named to the ex- Lake may be safely used in coloring tent that such other impurities may be drugs, including those intended for use avoided by good manufacturing prac- in the area of the eye, subject to the tice: restrictions on the use of color addi- tives in § 70.5(b) and (c) of this chapter, Volatile matter (at 100 °C.), not more than in amounts consistent with current 2.0 percent. good manufacturing practice. Matter insoluble in acetone, not more than (2) Other lakes of FD&C Red No. 40 1.0 percent. may be safely used in coloring drugs, Anthranilic acid, not more than 0.2 percent. N,N-(β,β′-Dihydroxy-diethyl) aniline, not subject to the restrictions on the use of more than 0.2 percent. color additives in § 70.5 of this chapter, Subsidiary colors, not more than 3.0 percent. in amounts consistent with current Lead (as Pb), not more than 20 parts per mil- good manufacturing practice. lion. (c) Labeling. The label of the color ad- Arsenic (as As), not more than 3 parts per ditive and any lakes or mixtures pre- million. pared therefrom intended solely or in Total color, not less than 95.0 percent. part for coloring purposes shall con- (c) Uses and restrictions. The color ad- form to the requirements of § 70.25 of ditive D&C Red No. 39 may be safely this chapter.
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(d) Certification. All batches of FD&C cordance with regulations in part 80 of Red No. 40 and lakes thereof shall be this chapter. certified in accordance with regula- [42 FR 15654, Mar. 22, 1977, as amended at 45 tions, in part 80 of this chapter. FR 62978, Sept. 23, 1980; 55 FR 18868, May 7, 1990] [42 FR 15654, Mar. 22, 1977, as amended at 59 FR 7636, Feb. 16, 1994] § 74.1705 FD&C Yellow No. 5. § 74.1602 D&C Violet No. 2. (a) Identity and specifications. (1) The color additive FD&C Yellow No. 5 shall (a) Identity. (1) The color additive conform in identity and specifications D&C Violet No. 2 is principally 1-hy- to the requirements of § 74.705 (a)(1) and droxy -4-[(4-methylphenyl)amino]-9,10- (b). anthracenedione. (2) FD&C Yellow No. 5 Aluminum (2) Color additive mixtures for use in Lake shall be prepared in accordance externally applied drugs made with with the requirements of § 82.51 of this D&C Violet No. 2 may contain only chapter. those diluents that are suitable and (3) Color additive mixtures for drug that are listed in part 73 of this chapter use made with FD&C Yellow No. 5 may as safe for use in color additive mix- contain only those diluents that are tures for coloring externally applied suitable and are listed in part 73 of this drugs. chapter as safe for use in color additive mixtures for coloring drugs. (b) Specifications. D&C Violet No. 2 (b) Uses and restrictions. (1) FD&C Yel- shall conform to the following speci- low No. 5 may be safely used for color- fications and shall be free from impuri- ing drugs generally, including drugs in- ties, other than those named, to the ex- tended for use in the area of the eye, in tent that such other impurities can be amounts consistent with current good avoided by good manufacturing prac- manufacturing practice. tice: (2) FD&C Yellow No. 5 Aluminum Volatile matter (at 135 °C.), not more than Lake may be safely used for coloring 2.0 percent. drugs intended for use in the area of Matter insoluble in both carbon tetra- the eye, when prepared in accordance chloride and water, not more than 0.5 per- with § 82.51 of this chapter. cent. (c) Labeling requirements. (1) The label p- Toluidine, not more than 0.2 percent. of the color additive and any mixtures 1-Hydroxy-9,10-anthracenedione, not more intended solely or in part for coloring than 0.5 percent. purposes prepared therefrom shall con- 1,4-Dihydroxy-9,10-anthracenedione, not form to the requirements of § 70.25 of more than 0.5 percent. this chapter. Subsidiary colors, not more than 1.0 percent. (2) The label of OTC and prescription Lead (as Pb), not more than 20 parts per mil- drug products intended for human use lion. administered orally, nasally, rectally, Arsenic (as As), not more than 3 parts per or vaginally, or for use in the area of million. the eye, containing FD&C Yellow No. 5 Total color, not less than 96.0 percent. shall specifically declare the presence (c) Uses and restrictions. The color ad- of FD&C Yellow No. 5 by listing the color additive using the names FD&C ditive D&C Violet No. 2 may be safely Yellow No. 5 and tartrazine. The label used for coloring externally applied shall bear a statement such as ‘‘Con- drugs in amounts consistent with good tains FD&C Yellow No. 5 (tartrazine) manufacturing practice. as a color additive’’ or ‘‘Contains color (d) Labeling. The label of the color ad- additives including FD&C Yellow No. 5 ditive and any mixtures prepared (tartrazine).’’ The labels of certain therefrom intended solely or in part for drug products subject to this labeling coloring purposes shall conform to the requirement that are also cosmetics, requirements of § 70.25 of this chapter. such as: antibacterial mouthwashes (e) Certification. All batches of D&C and fluoride toothpastes, need not com- Violet No. 2 shall be certified in ac- ply with this requirement provided
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they comply with the requirements of cordance with regulations in part 80 of § 701.3 of this chapter. this chapter. (3) For prescription drugs for human [51 FR 41782, Nov. 19, 1986, as amended at 52 use containing FD&C Yellow No. 5 that FR 21508, June 8, 1987; 53 FR 49138, Dec. 6, are administered orally, nasally, 1988] vaginally, or rectally, or for use in the area of the eye, the labeling required § 74.1707 D&C Yellow No. 7. by § 201.100(d) of this chapter shall, in (a) Identity. (1) The color additive addition to the label statement re- D&C Yellow No. 7 is principally fluo- quired under paragraph (c)(2) of this rescein. section, bear the warning statement (2) Color additive mixtures for use in ‘‘This product contains FD&C Yellow externally applied drugs made with No. 5 (tartrazine) which may cause al- D&C Yellow No. 7 may contain only lergic-type reactions (including bron- those diluents that are suitable and chial asthma) in certain susceptible that are listed in part 73 of this chapter persons. Although the overall incidence for use in color additive mixtures for of FD&C Yellow No. 5 (tartrazine) sen- coloring externally applied drugs. sitivity in the general population is (b) Specifications. D&C Yellow No. 7 low, it is frequently seen in patients shall conform to the following speci- who also have aspirin hyper- fications and shall be free from impuri- sensitivity.’’ This warning statement ties other than those named to the ex- shall appear in the ‘‘Precautions’’ sec- tent that such impurities may be tion of the labeling. avoided by good manufacturing prac- (d) Certification. All batches of FD&C tice: Yellow No. 5 shall be certified in ac- cordance with regulations in part 80 of Sum of water and chlorides and sulfates (cal- this chapter. culated as sodium salts), not more than 6 percent. [42 FR 15654, Mar. 22, 1977, as amended at 44 Matter insoluble in alkaline water, not more FR 37220, June 26, 1979; 50 FR 35782, Sept. 4, than 0.5 percent. 1985; 51 FR 24519, July 7, 1986; 59 FR 60897, Resorcinol, not more than 0.5 percent. Nov. 29, 1994] Phthalic acid, not more than 0.5 percent. 2-2,4-(Dihydroxybenzoyl) benzoic acid, not § 74.1706 FD&C Yellow No. 6. more than 0.5 percent. Lead (as Pb), not more than 20 parts per mil- (a) Identity and specifications. (1) The lion. color additive FD&C Yellow No. 6 shall Arsenic (as As), not more than 3 parts per conform in identity and specifications million. to the requirements of § 74.706(a)(1) and Mercury (as Hg), not more than 1 part per (b). million. (2) Color additive mixtures for drug Total color, not less than 94 percent. use made with FD&C Yellow No. 6 may (c) Uses and restrictions. D&C Yellow contain only those diluents that are No. 7 may be safely used in externally suitable and that are listed in part 73 applied drugs in amounts consistent of this chapter as safe for use in color with good manufacturing practice. additive mixtures for coloring drugs. (d) Labeling. The label of the color ad- (b) Uses and restrictions. FD&C Yellow ditive and any mixtures prepared No. 6 may be safely used for coloring therefrom intended solely or in part for drugs generally in amounts consistent coloring purposes shall conform to the with current good manufacturing prac- requirements of § 70.25 of this chapter. tice. (e) Certification. All batches of D&C (c) Labeling requirements. (1) The label Yellow No. 7 shall be certified in ac- of the color additive and any mixtures cordance with regulations in part 80 of intended solely or in part for coloring this chapter. purposes prepared therefrom shall con- form to the requirements of § 70.25 of § 74.1707a Ext. D&C Yellow No. 7. this chapter. (a) Identity. (1) The color additive (2) [Reserved] Ext. D&C Yellow No. 7 is principally (d) Certification. All batches of FD&C the disodium salt of 8-hydroxy-5,7-di- Yellow No. 6 shall be certified in ac- nitro-2-naphthalenesulfonic acid.
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(2) Color additive mixtures for drug Sum of water and chlorides and sulfates (cal- use made with Ext. D&C Yellow No. 7 culated as sodium salts), not more than 15 may contain only those diluents that percent. are suitable and that are listed in part Matter insoluble in alkaline water, not more than 0.3 percent. 73 of this chapter as safe for use in Resorcinol, not more than 0.5 percent. color additive mixtures for coloring ex- Phthalic acid, not more than 1 percent. ternally applied drugs. 2-(2,4-Dihydroxybenzoyl) benzoic acid, not (b) Specifications. Ext. D&C Yellow more than 0.5 percent. No. 7 shall conform to the following Lead (as Pb), not more than 20 parts per mil- specifications and shall be free from lion. impurities, other than those named, to Arsenic (as As), not more than 3 parts per million. the extent that such other impurities Mercury (as Hg), not more than 1 part per may be avoided by good manufacturing million. practice: Total color, not less than 85 percent. Sum of volatile matter (at 135 °C) and (c) Uses and restrictions. D&C Yellow chlorides and sulfates (calculated as so- No. 8 may be safely used in externally dium salts), not more than 15 percent. applied drugs in amounts consistent Water-insoluble matter, not more than 0.2 with good manufacturing practice. percent. 1-Naphthol, not more than 0.2 percent. (d) Labeling. The label of the color ad- 2,4-Dinitro-1-naphthol, not more than 0.03 ditive and any mixtures prepared percent. therefrom intended solely or in part for Lead (as Pb), not more than 20 parts per mil- coloring purposes shall conform to the lion. requirements of § 70.25 of this chapter. Arsenic (as As), not more than 3 parts per (e) Certification. All batches of D&C million. Yellow No. 8 shall be certified in ac- Mercury (as Hg), not more than 1 part per cordance with regulations in part 80 of million. Total color, not less than 85 percent. this chapter. (c) Uses and restrictions. Ext. D&C § 74.1710 D&C Yellow No. 10. Yellow No. 7 may be safely used in ex- (a) Identity. (1) The color additive ternally applied drugs in amounts con- D&C Yellow No. 10 is a mixture of the sistent with good manufacturing prac- sodium salts of the mono- and tice. disulfonic acids of 2-(2-quinolinyl)-1H- (d) Labeling. The label of the color ad- indene-1,3 (2H)-dione consisting prin- ditive and any mixtures prepared cipally of the sodium salts of 2-(2,3- therefrom intended solely or in part for dihydro-1,3-dioxo-1H-indene-2-yl)-6- coloring purposes shall conform to the quinolinesulfonic acid and 2-(2,3- requirements of § 70.25 of this chapter. dihydro-1,3-dioxo-1H-indene-2-yl)-8- (e) Certification. All batches of Ext. quinolinesulfonic acid with lesser D&C Yellow No. 7 shall be certified in amounts of the disodium salts of the accordance with regulations in part 80 disulfonic acids of 2-(2-quinolinyl)-1H- of this chapter. indene-1,3(2H)-dione (CAS Reg. No. 8004–92–0). D&C Yellow No. 10 is manu- § 74.1708 D&C Yellow No. 8. factured by condensing quinaldine with (a) Identity. (1) The color additive phthalic anhydride to give the D&C Yellow No. 8 is principally the di- unsulfonated dye, which is then sulfo- sodium salt of fluorescein. nated with oleum. (2) Color additive mixtures for use in (2) Color additive mixtures made externally applied drugs made with with D&C Yellow No. 10 for drug use D&C Yellow No. 8 may contain only may contain only those diluents that those diluents that are suitable and are suitable and that are listed in part that are listed in part 73 of this chapter 73 of this chapter as safe for use in for use in color additive mixtures for color additive mixtures for coloring coloring externally applied drugs. drugs. (b) Specifications. D&C Yellow No. 8 (b) Specifications. The color additive shall be free from impurities other D&C Yellow No. 10 shall conform to the than those named to the extent that following specifications and shall be such impurities may be avoided by free from impurities other than those good manufacturing practice: named to the extent that such other
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impurities may be avoided by current additive mixtures for coloring exter- good manufacturing practice: nally applied drugs. (b) Specifications. D&C Yellow No. 11 Sum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as so- shall conform to the following speci- dium salts), not more than 15 percent. fications and shall be free from impuri- Matter insoluble in both water and chloro- ties, other than those named, to the ex- form, not more than 0.2 percent. tent that such other impurities may be Total sulfonated quinaldines, sodium salts, avoided by good manufacturing prac- not more than 0.2 percent. tice: Total sulfonated phthalic acids, sodium ° salts, not more than 0.2 percent. Volatile matter (at 135 C), not more than 1 2-(2-Quinolinyl)-1H-indene-1,3 (2H)-dione, not percent. more than 4 parts per million. Ethyl alcohol-insoluble matter, not more Sum of sodium salts of the monosulfonates than 0.4 percent. of 2-(2-quinolinyl)-1H-indene-1,3 (2H)-dione, Phthalic acid, not more than 0.3 percent. not less than 75 percent. Quinaldine, not more than 0.2 percent. Subsidiary colors, not more than 5 percent. Sum of sodium salts of the disulfonates of 2- (2-quinolinyl)-1H-indene-1,3 (2H)-dione, not Lead (as Pb), not more than 20 parts per mil- more than 15 percent. lion. Arsenic (as As), not more than 3 parts per 2-(2,3-Dihydro-1,3-dioxo-1H-indene-2-yl)-6, 8- million. quinolinedisulfonic acid, disodium salt, not Mercury (as Hg), not more than 1 part per more than 3 percent. million. Diethyl ether soluble matter other than that Total color, not less than 96 percent. specified, not more than 2 parts per mil- lion, using added 2-(2-quinolinyl)-1H-in- (c) Uses and restrictions. D&C Yellow dene-1,3 (2H)-dione for calibration. No. 11 may be safely used in externally Lead (as Pb), not more than 20 parts per mil- applied drugs in amounts consistent lion. with good manufacturing practice. Arsenic (as As), not more than 3 parts per (d) Labeling. The label of the color ad- million. Mercury (as Hg), not more than 1 part per ditive and any mixtures prepared million. therefrom intended solely or in part for Total color, not less than 85 percent. coloring purposes shall conform to the requirements of § 70.25 of this chapter. (c) Uses and restrictions. The color ad- (e) Certification. All batches of D&C ditive D&C Yellow No. 10 may be safely Yellow No. 11 shall be certified in ac- used for coloring drugs generally in cordance with regulations in part 80 of amounts consistent with current good this chapter. manufacturing practice. (d) Labeling. The label of the color ad- ditive and any mixtures prepared Subpart C—Cosmetics therefrom and intended solely or in § 74.2101 FD&C Blue No. 1. part for coloring purposes shall con- form to the requirements of § 70.25 of (a) Identity. The color additive FD&C this chapter. Blue No. 1 is principally the disodium (e) Certification. All batches of D&C salt of ethyl[4-[p-[ethyl(m- α Yellow No. 10 shall be certified in ac- sulfobenzyl)amino]- -(o- cordance with regulations in part 80 of sulfophenyl)benzylidene]-2,5- this chapter. cyclohexadien-1-ylidene](m- sulfobenzyl)ammonium hydroxide [48 FR 39219, Aug. 30, 1983, as amended at 49 inner salt with smaller amounts of the FR 8432, Mar. 7, 1984] isomeric disodium salts of ethyl[4-[p- [ethyl(p-sulfobenzyl)amino]-α-(o- § 74.1711 D&C Yellow No. 11. sulfophenyl)benzylidene]-2,5- (a) Identity. (1) The color additive cyclohexadien-1-ylidene](p- D&C Yellow No. 11 is principally 2-(2- sulfobenzyl)ammonium hydroxide quinolyl)-1,3-indandione. inner salt and ethyl[4-[p-[ethyl(o- (2) Color additive mixtures, for drug sulfobenzyl)amino]-α-(o- use made with D&C Yellow No. 11 may sulfophenyl)benzylidene]-2,5- contain only those diluents that are cyclohexadien-1-ylidene](o- suitable and that are listed in part 73 sulfobenzyl)ammonium hydroxide of this chapter as safe for use in color inner salt. Additionally, FD&C Blue
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No. 1 is manufactured by the acid cata- consistent with good manufacturing lyzed condensation of one mole of so- practice. dium 2-formylbenzenesulfonate with (c) Labeling. The label of the color ad- two moles from a mixture consisting ditive shall conform to the require- principally of 3- ments of § 70.25 of this chapter. [(ethylphenylamino)methyl] (d) Certification. All batches of D&C benzenesulfonic acid, and smaller Blue No. 4 shall be certified in accord- amounts of 4- ance with regulations in part 80 of this [(ethylphenylamino)methyl] chapter. benzenesulfonic acid and 2- [(ethylphenylamino)methyl] § 74.2151 D&C Brown No. 1. benzenesulfonic acid to form the leuco (a) Identity. The color additive D&C base. The leuco base is then oxidized Brown No. 1 is a mixture of the sodium with lead dioxide and acid, or with di- salts of 4[[5-[(dialkylphenyl)- azo]-2,4- chromate and acid, or with manganese dihydroxyphenyl]azo]-benzene sulfonic dioxide and acid to form the dye. The acid. The alkyl group is principally the intermediate sodium 2- methyl group. formylbenzenesulfonate is prepared (b) Specifications. D&C Brown No. 1 from 2-chlorobenzaldehyde and sodium shall conform to the following speci- sulfite. fications and shall be free from impuri- (b) Specifications. (1) The color addi- ties other than those named to the ex- tive FD&C Blue No. 1 shall conform in tent that such other impurities may be specifications to the requirements of avoided by good manufacturing prac- § 74.101(b). tice: (2) FD&C Blue No. 1 Aluminum Lake shall be prepared in accordance with Sum of volatile matter (at 135 °C) and the requirements of § 82.51 of this chap- chlorides and sulfates (calculated as so- ter. dium salts), not more than 16 percent. (c) Uses and restrictions. (1) FD&C Water-insoluble matter, not more than 0.2 Blue No. 1 may be safely used for color- percent. Sulfanilic acid, sodium salt, not more than ing cosmetics generally, including cos- 0.2 percent. metics intended for use in the area of Resorcinol, not more than 0.2 percent. the eye, in amounts consistent with Xylidines, not more than 0.2 percent. current good manufacturing practice. Disodium salt of 4[[5-[(4-sulfophenyl)-azo]- (2) FD&C Blue No. 1 Aluminum Lake 2,4-dihydroxyphenyl]azo] benzenesulfonic may be safely used for coloring cos- acid, not more than 3 percent. metics intended for use in the area of Monosodium salt of 4[[5-[(2,4-dimethyl- the eye, in amounts consistent with phenyl)azo] -2,4-dihydroxyphenyl]azo] current good manufacturing practice. benzenesulfonic acid, not less than 29 per- cent and not more than 39 percent. (d) Labeling. The label of the color ad- Monosodium salt of 4[[5-[(2,5-dimethyl- ditive shall conform to the require- phenyl)azo] -2,4-dihydroxyphenyl]azo] ments of § 70.25 of this chapter. benzenesulfonic acid, not less than 12 per- (e) Certification. All batches of FD&C cent and not more than 17 percent. Blue No. 1 shall be certified in accord- Monosodium salt of 4[[5-[(2,3-dimethyl- ance with regulations in part 80 of this phenyl)azo] - 2,4-dihydroxyphenyl]azo] chapter. benzenesulfonic acid, not less than 6 per- cent and not more than 13 percent. [47 FR 42565, Sept. 28, 1982, as amended at 58 Monosodium salt of 4[[5-[(2-ethylphenyl)- FR 17511, Apr. 5, 1993; 59 FR 7638, Feb. 16, azo]-2,4-dihydroxyphenyl]-azo] 1994] benzenesulfonic acid, not less than 5 per- cent and not more than 12 percent. § 74.2104 D&C Blue No. 4. Monosodium salt of 4[[5-[(3,4-dimethyl- (a) Identity and specifications. The phenyl)azo] -2,4-dihydroxyphenyl]azo] color additive D&C Blue No. 4 shall benzenesulfonic acid, not less than 3 per- conform in identity and specifications cent and not more than 9 percent. Monosodium salt of 4[[5-[(2,6-dimethyl- to the requirements of § 74.1104(a)(1) phenyl)azo] -2,4-dihydroxyphenyl]azo] and (b). benzenesulfonic acid, not less than 3 per- (b) Uses and restrictions. D&C Blue No. cent and not more than 8 percent. 4 may be safely used for coloring exter- Monosodium salt of 4[[5-[(4-ethylphenyl) nally applied cosmetics in amounts azo]-2,4-dihydroxyphenyl]-azo]
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benzenesulfonic acid, not less than 2 per- ance with regulations in part 80 of this cent and not more than 8 percent. chapter. Lead (as Pb), not more than 20 parts per mil- lion. [47 FR 24285, June 4, 1982, as amended at 59 Arsenic (as As), not more than 3 parts per FR 40805, Aug. 10, 1994] million. Mercury (as Hg), not more than 1 part per § 74.2206 D&C Green No. 6. million. Total color, not less than 84 percent. (a) Identity and specifications. The color additive D&C Green No. 6 shall (c) Uses and restrictions. D&C Brown conform in identity and specifications No. 1 may be safely used for coloring to the requirements of § 74.1206 (a) and externally applied cosmetics in (b). amounts consistent with good manu- (b) Uses and restrictions. D&C Green facturing practice. No. 6 may be safely used for coloring (d) Labeling. The label of the color ad- externally applied cosmetics in ditive shall conform to the require- amounts consistent with good manu- ments of § 70.25 of this chapter. facturing practice. (e) Certification. All batches of D&C (c) Labeling requirements. The label of Brown No. 1 shall be certified in ac- the color additive shall conform to the cordance with regulations in part 80 of requirements of § 70.25 of this chapter. this chapter. (d) Certification. All batches of D&C § 74.2203 FD&C Green No. 3. Green No. 6 shall be certified in accord- ance with regulations in part 80 of this (a) Identity and specifications. The chapter. color additive FD&C Green No. 3 shall conform in identity and specifications [47 FR 14146, Apr. 4, 1982, as amended at 51 to the requirements of § 74.203(a)(1) and FR 9784, Mar. 21, 1986] (b). (b) Uses and restrictions. The color ad- § 74.2208 D&C Green No. 8. ditive FD&C Green No. 3 may be safely (a) Identity and specifications. The used for coloring cosmetics generally color additive D&C Green No. 8 shall in amounts consistent with current conform in identity and specifications good manufacturing practice. to the requirements of § 74.1208(a)(1) (c) Labeling. The label of the color ad- and (b). ditive shall conform to the require- (b) Uses and restrictions. D&C Green ments of § 70.25 of this chapter. No. 8 may be safely used for coloring (d) Certification. All batches of FD&C externally applied cosmetics in Green No. 3 shall be certified in accord- amounts not exceeding 0.01 percent by ance with regulations in part 80 of this weight of the finished cosmetic prod- chapter. uct. [47 FR 52144, Nov. 19, 1982] (c) Labeling. The label of the color ad- ditive shall conform to the require- § 74.2205 D&C Green No. 5. ments of § 70.25 of this chapter. (a) Identity and specifications. The (d) Certification. All batches of D&C color additive D&C Green No. 5 shall Green No. 8 shall be certified in accord- conform in identity and specifications ance with regulations in part 80 of this to the requirements of § 74.1205 (a)(1) chapter. and (b)(2). (b) Uses and restrictions. D&C Green § 74.2254 D&C Orange No. 4. No. 5 may be safely used for coloring (a) Identity and specifications. The cosmetics generally, including cos- color additive D&C Orange No. 4 shall metics intended for use in the area of conform in identity and specifications the eye, in amounts consistent with to the requirements of § 74.1254 (a)(1) current good manufacturing practice. and (b). (c) Labeling requirements. The label of (b) Uses and restrictions. D&C Orange the color additive shall conform to the No. 4 may be safely used for coloring requirements of § 70.25 of this chapter. externally applied cosmetics in (d) Certification. All batches of D&C amounts consistent with good manu- Green No. 5 shall be certified in accord- facturing practice.
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(c) Labeling. The label of the color ad- cordance with regulations in part 80 of ditive shall conform to the require- this chapter. ments of § 70.25 of this chapter. [46 FR 18954, Mar. 27, 1981] (d) Certification. All batches of D&C Orange No. 4 shall be certified in ac- § 74.2261 D&C Orange No. 11. cordance with regulations in part 80 of (a) Identity and specifications. The this chapter. color additive D&C Orange No. 11 shall [42 FR 52396, Sept. 30, 1977] conform in identity and specifications to the requirements of § 74.1261(a)(1) § 74.2255 D&C Orange No. 5. and (b). (a) Identity and specifications. The (b) Uses and restrictions. D&C Orange color additive D&C Orange No. 5 shall No. 11 may be safely used for coloring conform in identity and specifications externally applied cosmetics in to the requirements of § 74.1255 (a)(1) amounts consistent with good manu- and (b). facturing practice. (b) Uses and restrictions. D&C Orange (c) Labeling requirements. The label of No. 5 may be safely used for coloring the color additive shall conform to the mouthwashes and dentifrices that are requirements of § 70.25 of this chapter. ingested cosmetics in amounts con- (d) Certification. All batches of D&C sistent with current good manufac- Orange No. 11 shall be certified in ac- turing practice. D&C Orange No. 5 may cordance with regulations in part 80 of be safely used for coloring lipsticks this chapter. and other cosmetics intended to be ap- [46 FR 18954, Mar. 27, 1981] plied to the lips in amounts not exceed- ing 5.0 percent by weight of the fin- § 74.2304 FD&C Red No. 4. ished cosmetic products. D&C Orange (a) Identity and specifications. The No. 5 may be safely used for coloring color additive FD&C Red No. 4 shall externally applied cosmetics in conform in identity and specifications amounts consistent with current good to the requirements of § 74.1304(a)(1) manufacturing practice. and (b). (c) Labeling. The label of the color ad- (b) Uses and restrictions. FD&C Red ditive shall conform to the require- No. 4 may be safely used for coloring ments of § 70.25 of this chapter. externally applied cosmetics in (d) Certification. All batches of D&C amounts consistent with good manu- Orange No. 5 shall be certified in ac- facturing practice. cordance with regulations in part 80 of (c) Labeling. The label of the color ad- this chapter. ditive shall conform to the require- ments of § 70.25 of this chapter. [47 FR 49635, Nov. 2, 1982, as amended at 49 (d) Certification. All batches of FD&C FR 13342, Apr. 4, 1984] Red No. 4 shall be certified in accord- ance with regulations in part 80 of this § 74.2260 D&C Orange No. 10. chapter. (a) Identity and specifications. The color additive D&C Orange No. 10 shall § 74.2306 D&C Red No. 6. conform in identity and specifications (a) Identity and specifications.The to the requirements of § 74.1260(a)(1) color additive D&C Red No. 6 shall con- and (b). form in identity and specifications to (b) Uses and restrictions. D&C Orange the requirements of § 74.1306 (a)(1) and No. 10 may be safely used for coloring (b). externally applied cosmetics in (b) Uses and restrictions. The color ad- amounts consistent with good manu- ditive D&C Red No. 6 may be safely facturing practice. used for coloring cosmetics generally (c) Labeling requirements. The label of in amounts consistent with current the color additive shall conform to the good manufacturing practice. requirements of § 70.25 of this chapter. (c) Labeling requirements. The label of (d) Certification. All batches of D&C the color additive shall conform to the Orange No. 11 shall be certified in ac- requirements of § 70.25 of this chapter.
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(d) Certification. All batches of D&C (c) Labeling requirements. The label of Red No. 6 shall be certified in accord- the color additive shall conform to the ance with regulations in part 80 of this requirements of § 70.25 of this chapter. chapter. (d) Certification. All batches of D&C Red No. 21 shall be certified in accord- [47 FR 57688, Dec. 28, 1982] ance with regulations in part 80 of this chapter. § 74.2307 D&C Red No. 7 [47 FR 53846, Nov. 30, 1982] (a) Identity and specifications. The color additive D&C Red No. 7 shall con- § 74.2322 D&C Red No. 22. form in identity and specifications to (a) Identity and specifications. The the requirements of § 74.1307 (a)(1) and color additive D&C Red No. 22 shall (b). conform in identity and specifications (b) Uses and restrictions. The color ad- to the requirements of § 74.1322(a)(1) ditive D&C Red No. 7 may be safely and (b). used for coloring cosmetics generally (b) Uses and restrictions. The color ad- in amounts consistent with current ditive D&C Red No. 22 may be safely good manufacturing practice. used for coloring cosmetics generally (c) Labeling requirements. The label of in amounts consistent with current the color additive shall conform to the good manufacturing practice. requirements of § 70.25 of this chapter. (c) Labeling requirements. The label of (d) Certification. All batches of D&C the color additive shall conform to the Red No. 7 shall be certified in accord- requirements of § 70.25 of this chapter. ance with regulations in part 80 of this (d) Certification. All batches of D&C chapter. Red No. 22 shall be certified in accord- ance with regulations in part 80 of this [47 FR 57688, Dec. 28, 1982] chapter. § 74.2317 D&C Red No. 17. [47 FR 53846, Nov. 30, 1982] (a) Identity and specifications. The § 74.2327 D&C Red No. 27. color additive D&C Red No. 17 shall (a) Identity and specifications. The conform in identity and specifications color additive D&C Red No. 27 shall to the requirements of § 74.1317(a)(1) conform in identity and specifications and (b). to the requirements of § 74.1327 (a)(1) (b) Uses and restrictions. D&C Red No. and (b). 17 may be safely used for coloring ex- (b) Uses and restrictions. D&C Red No. ternally applied cosmetics in amounts 27 may be safely used for coloring cos- consistent with good manufacturing metics generally in amounts consistent practice. with current good manufacturing prac- (c) Labeling. The label of the color ad- tice. ditive shall conform to the require- (c) Labeling requirements. The label of ments of § 70.25 of this chapter. the color additive shall conform to the (d) Certification. All batches of D&C requirements of § 70.25 of this chapter. Red No. 17 shall be certified in accord- (d) Certification. All batches of D&C ance with regulations in part 80 of this Red No. 27 shall be certified in accord- chapter. ance with regulations in part 80 of this chapter. § 74.2321 D&C Red No. 21. [47 FR 42568, Sept. 28, 1982] (a) Identity and specifications. The color additive D&C Red No. 21 shall § 74.2328 D&C Red No. 28. conform in identity and specifications (a) Identity and specifications. The to the requirements of § 74.1321(a)(1) color additive D&C Red No. 28 shall and (b). conform in identity and specifications (b) Uses and restrictions. The color ad- to the requirements of § 74.1328 (a)(1) ditive D&C Red No. 21 may be safely and (b). used for coloring cosmetics generally (b) Uses and restrictions. D&C Red No. in amounts consistent with current 28 may be safely used for coloring cos- good manufacturing practice. metics generally in amounts consistent
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with current good manufacturing prac- used for coloring cosmetic lip products tice. in amounts not to exceed 3 percent (c) Labeling requirements. The label of total color by weight of the finished the color additive shall conform to the cosmetic products. D&C Red No. 33 requirements of § 70.25 of this chapter. may be safely used for coloring (d) Certification. All batches of D&C mouthwashes (including breath fresh- Red No. 28 shall be certified in accord- eners), dentifrices, and externally ap- ance with regulations in part 80 of this plied cosmetics in amounts consistent chapter. with current good manufacturing prac- [47 FR 42568, Sept. 28, 1982] tice. (c) Labeling requirements. The label of § 74.2330 D&C Red No. 30. the color additive and any mixtures (a) Identity and specifications. The prepared therefrom intended solely or color additive D&C Red No. 30 shall in part for coloring purposes shall con- conform in identity and specifications form to the requirements of § 70.25 of to the requirements of § 74.1330 (a)(1) this chapter. and (b). (d) Certification. All batches of D&C (b) Uses and restrictions. D&C Red No. Red No. 33 shall be certified in accord- 30 may be safely used for coloring cos- ance with regulations in part 80 of this metics generally in amounts consistent chapter. with current good manufacturing prac- [53 FR 33120, Aug. 30, 1988] tice. (c) Labeling requirements. The label of § 74.2334 D&C Red No. 34. the color additive shall conform to the requirements of § 70.25 of this chapter. (a) Identity and specifications. The (d) Certification. All batches of D&C color additive D&C Red No. 34 shall Red No. 30 shall be certified in accord- conform in identity and specifications ance with regulations in part 80 of this to the requirements of § 74.1334(a)(1) chapter. and (b). (b) Uses and restrictions. D&C Red No. [47 FR 22511, May 25, 1982] 34 may be safely used for coloring ex- § 74.2331 D&C Red No. 31. ternally applied cosmetics in amounts consistent with good manufacturing (a) Identity and specifications. The practice. color additive D&C Red No. 31 shall (c) Labeling. The label of the color ad- conform in identity and specifications ditive shall conform to the require- to the requirements of § 74.1331(a)(1) ments of § 70.25 of this chapter. and (b). (b) Uses and restrictions. D&C Red No. (d) Certification. All batches of D&C 31 may be safely used for coloring ex- Red No. 34 shall be certified in accord- ternally applied cosmetics in amounts ance with regulations in part 80 of this consistent with good manufacturing chapter. practice. (c) Labeling. The label of the color ad- § 74.2336 D&C Red No. 36. ditive shall conform to the require- (a) Identity and specifications. The ments of § 70.25 of this chapter. color additive D&C Red No. 36 shall (d) Certification. All batches of D&C conform in identity and specifications Red No. 31 shall be certified in accord- to the requirements of § 74.1336 (a)(1) ance with regulations in part 80 of this and (b). chapter. (b) Uses and restrictions. The color ad- ditive D&C Red No. 36 may be safely § 74.2333 D&C Red No. 33. used for coloring cosmetic lip products (a) Identity and specifications. The in amounts not to exceed 3 percent color additive D&C Red No. 33 shall total color by weight of the finished conform in identity and specifications cosmetic products. D&C Red No. 36 to the requirements of § 74.1333(a) (1) may be safely used for coloring exter- and (b). nally applied cosmetics in amounts (b) Uses and restrictions. The color ad- consistent with current good manufac- ditive D&C Red No. 33 may be safely turing practice.
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(c) Labeling requirements. The label of cosmetics in amounts consistent with the color additive shall conform to the good manufacturing practice. requirements of § 70.25 of this chapter. (c) Labeling. The label of the color ad- (d) Certification. All batches of D&C ditive shall conform to the require- Red No. 36 shall be certified in accord- ments of § 70.25 of this chapter. ance with regulations in part 80 of this (d) Certification. All batches of D&C chapter. Violet No. 2 shall be certified in ac- cordance with regulations in part 80 of [53 FR 29031, Aug. 2, 1988] this chapter. § 74.2340 FD&C Red No. 40. § 74.2602a Ext. D&C Violet No. 2. (a) Identity and specifications. (1) The color additive FD&C Red No. 40 shall (a) Identity. The color additive Ext. conform in identity and specifications D&C Violet No. 2 is principally the to the requirements of § 74.340(a)(1) and monosodium salt of 2-[(9,10-dihydro-4- (b) of this chapter. hydroxy -9,10-dioxo-1-anthracenyl) (2) The listing of this color additive amino]-5-methyl-benzenesulfonic acid. includes lakes prepared as described in (b) Specifications. Ext. D&C Violet No. §§ 82.51 and 82.1051 of this chapter, ex- 2 shall conform to the following speci- cept that the color additive used is fications and shall be free from impuri- FD&C Red No. 40 and the resultant ties, other than those named, to the ex- lakes meet the specification and label- tent that such other impurities may be ing requirements prescribed by § 82.51 avoided by good manufacturing prac- or § 82.1051 of this chapter. tice: (b) Uses and restrictions. FD&C Red Sum of volatile matter (at 135 °C) and No. 40 may be safely used in coloring chlorides and sulfates (calculated as so- cosmetics generally, except that only dium salts), not more than 18 percent. FD&C Red No. 40 and FD&C Red No. 40 Water-insoluble matter, not more than 0.4 Aluminum Lake may be safely used in percent. 1-Hydroxy-9,10-anthracenedione, not more coloring cosmetics intended for use in than 0.2 percent. the area of the eye. These uses are sub- 1,4-Dihydroxy-9,10-anthracenedione, not ject to the following restrictions: more than 0.2 percent. (1) The color additive may be used in p- Toluidine, not more than 0.1 percent. amounts consistent with current good p- Toluidine sulfonic acids, sodium salts, not manufacturing practice. more than 0.2 percent. (2) The color additive shall not be ex- Subsidiary colors, not more than 1 percent. posed to oxidizing or reducing agents Lead (as Pb), not more than 20 parts per mil- lion. that may affect the integrity of the Arsenic (as As), not more than 3 parts per color additives or any other condition million. that may affect their integrity. Mercury (as Hg), not more than 1 part per (c) Labeling. The label of the color ad- million. ditive shall conform to the require- Total color, not less than 80 percent. ments of § 70.25 of this chapter. (c) Uses and restrictions. The color ad- (d) Certification. All batches of FD&C ditive Ext. D&C Violet No. 2 may be Red No. 40 shall be certified in accord- safely used for coloring externally ap- ance with regulations in part 80 of this plied cosmetics in amounts consistent chapter. with good manufacturing practice. [42 FR 15654, Mar. 22, 1977, as amended at 59 (d) Labeling. The label of the color ad- FR 7636, Feb. 16, 1994] ditive shall conform to the require- ments of § 70.25 of this chapter. § 74.2602 D&C Violet No. 2. (e) Certification. All batches of Ext. (a) Identity and specifications. The D&C Violet No. 2 shall be certified in color additive D&C Violet No. 2 shall accordance with regulations in part 80 conform in identity and specifications of this chapter. to the requirements of § 74.1602(a)(1) and (b). § 74.2705 FD&C Yellow No. 5. (b) Uses and restrictions. The color ad- (a) Identity. The color additive FD&C ditive D&C Violet No. 2 may be safely Yellow No. 5 is principally the tri- used for coloring externally applied sodium salt of 4,5-dihydro-5-oxo-(1-4-
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sulfophenyl)-4-[(4-sulfophenyl)azo]-1H- Lead (as Pb), not more than 10 parts per mil- pyrazole-3-carboxylic acid (CAS Reg. lion. No. 1934–21–0). To manufacture the ad- Arsenic (as As), not more than 3 parts per million. ditive, 4-aminobenzenesulfonic acid is Mercury (as Hg), not more than 1 part per diazotized using hydrochloric acid and million. sodium nitrite. The diazo compound is Total color, not less than 87 percent. coupled with 4,5-dihydro-5-oxo-1-(4- (2) FD&C Yellow No. 5 Aluminum sulfophenyl)-1H-pyrazole-3-carboxylic Lake shall be prepared in accordance acid or with the methyl ester, the with the requirements of § 82.51 of this ethyl ester, or a salt of this carboxylic chapter. acid. The resulting dye is purified and (c) Uses and restrictions. (1) FD&C Yel- isolated as the sodium salt. low No. 5 may be safely used for color- (b) Specifications. (1) FD&C Yellow ing cosmetics generally, including cos- No. 5 shall conform to the following metics intended for use in the area of specifications and shall be free from the eye, in amounts consistent with impurities other than those named to current good manufacturing practice. the extent that such other impurities (2) FD&C Yellow No. 5 Aluminum may be avoided by good manufacturing Lake may be safely used for coloring practice: cosmetics intended for use in the area Sum of volatile matter at 135 °C (275 °F) and of the eye, subject to the restrictions chlorides and sulfates (calculated as so- on use of color additives in § 70.5(b) and dium salts), not more than 13 percent. (c) of this chapter, in amounts con- Water-insoluble matter, not more than 0.2 sistent with current good manufac- percent. turing practice. 4,4′-[4,5-Dihydro-5-oxo-4-[(4- (d) Labeling. The label of the color ad- sulfophenyl)hydrazono]-1H-pyrazol-1,3- ditive shall conform to the require- diyl]bis[benzenesulfonic acid], trisodium salt, not more than 1 percent. ments of § 70.25 of this chapter. 4-[(4′,5-Disulfo[1,1′-biphenyl]-2-yl)hydrazono]- (e) Certification. All batches of FD&C 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyr- Yellow No. 5 shall be certified in ac- azole-3-carboxylic acid, tetrasodium salt, cordance with regulations in part 80 of not more than 1 percent. this chapter. Ethyl or methyl 4,5-dihydro-5-oxo-1-(4- sulfophenyl)-4-[(4-sulfophenyl)hydrazono]- [50 FR 35782, Sept. 4, 1985, as amended at 51 1H-pyrazole-3-carboxylate, disodium salt, FR 24524, July 7, 1986; 59 FR 60898, Nov. 29, not more than 1 percent. 1994] Sum of 4,5-dihydro-5-oxo-1-phenyl-4-[(4- sulfophenyl)azo]-1H-pyrazole-3-carboxylic § 74.2706 FD&C Yellow No. 6. acid, disodium salt, and 4,5-dihydro-5-oxo- (a) Identity and specifications. The 4-(phenylazo)-1-(4-sulfophenyl)-1H-pyr- color additive FD&C Yellow No. 6 shall azole-3-carboxylic acid, disodium salt, not conform in identity and specifications more than 0.5 percent. to the requirements of § 74.706 (a)(1) and 4-Aminobenzenesulfonic acid, sodium salt, not more than 0.2 percent. (b). 4,5-Dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyr- (b) Uses and restrictions. FD&C Yellow azole-3-carboxylic acid, disodium salt, not No. 6 may be safely used for coloring more than 0.2 percent. cosmetics generally in amounts con- Ethyl or methyl 4,5-dihydro-5-oxo-1-(4- sistent with current good manufac- sulfophenyl)-1H-pyrazole-3-carboxylate, so- turing practice. dium salt, not more than 0.1 percent. (c) Labeling. The label of the color ad- 4,4′-(1-Triazene-1,3-diyl)bis[benzenesulfonic ditive shall conform to the require- acid], disodium salt, not more than 0.05 ments of § 70.25 of this chapter. percent. (d) Certification. All batches of FD&C 4-Aminoazobenzene, not more than 75 parts per billion. Yellow No. 6 shall be certified in ac- 4-Aminobiphenyl, not more than 5 parts per cordance with regulations in part 80 of billion. this chapter. Aniline, not more than 100 parts per billion. [51 FR 41782, Nov. 19, 1986] Azobenzene, not more than 40 parts per bil- lion. § 74.2707 D&C Yellow No. 7. Benzidine, not more than 1 part per billion. 1,3-Diphenyltriazene, not more than 40 parts (a) Identity and specifications. The per billion. color additive D&C Yellow No. 7 shall
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conform in identity and specifications to the requirements of § 74.1710(a)(1) to the requirements of § 74.1707(a)(1) and (b). and (b). (b) Uses and restrictions. The color ad- (b) Uses and restrictions. D&C Yellow ditive D&C Yellow No. 10 may be safely No. 7 may be safely used for coloring used for coloring cosmetics generally externally applied cosmetics in in amounts consistent with current amounts consistent with good manu- good manufacturing practice. facturing practice. (c) Labeling. The label of the color ad- (c) Labeling. The label of the color ad- ditive shall conform to the require- ditive shall conform to the require- ments of § 70.25 of this chapter. ments of § 70.25 of this chapter. (d) Certification. All batches of D&C (d) Certification. All batches of D&C Yellow No. 10 shall be certified in ac- Yellow No. 7 shall be certified in ac- cordance with regulations in part 80 of cordance with regulations in part 80 of this chapter. this chapter. [48 FR 39220, Aug. 30, 1983, as amended at 49 FR 8432, Mar. 7, 1984] § 74.2707a Ext. D&C Yellow No. 7. (a) Identity and specifications. The § 74.2711 D&C Yellow No. 11. color additive Ext. D&C Yellow No. 7 (a) Identity and specifications. The shall conform in identity and specifica- color additive D&C Yellow No. 11 shall tions to the requirements of § 74.1707a conform in identity and specifications (a)(1) and (b). to the requirements of § 74.1711(a)(1) (b) Uses and restrictions. Ext. D&C and (b). Yellow No. 7 may be safely used for (b) Uses and restrictions. D&C Yellow coloring externally applied cosmetics No. 11 may be safely used for coloring in amounts consistent with good manu- externally applied cosmetics in facturing practice. amounts consistent with good manu- (c) Labeling. The label of the color ad- facturing practice. ditive shall conform to the require- (c) Labeling. The label of the color ad- ments of § 70.25 of this chapter. ditive shall conform to the require- (d) Certification. All batches of Ext. ments of § 70.25 of this chapter. D&C Yellow No. 7 shall be certified in (d) Certification. All batches of D&C accordance with regulations in part 80 Yellow No. 11 shall be certified in ac- of this chapter. cordance with regulations in part 80 of this chapter. § 74.2708 D&C Yellow No. 8. (a) Identity and specifications. The Subpart D—Medical Devices color additive D&C Yellow No. 8 shall conform in identity and specifications § 74.3045 [Phthalocyaninato(2-)] cop- to the requirements of § 74.1708(a)(1) per. and (b). (a) Identity. The color additive is (b) Uses and restrictions. D&C Yellow [phthalocyaninato(2-)] copper (CAS No. 8 may be safely used for coloring Reg. No. 147–14–8) having the structure externally applied cosmetics in shown in Colour Index No. 74160. amounts consistent with good manu- (b) Specifications. The color additive facturing practice. [phthalocyaninato(2-)] copper shall (c) Labeling. The label of the color ad- conform to the following specifications ditive shall conform to the require- and shall be free from impurities other ments of § 70.25 of this chapter. than those named to the extent that (d) Certification. All batches of D&C such impurities may be avoided by cur- Yellow No. 8 shall be certified in ac- rent good manufacturing practice: cordance with regulations in part 80 of this chapter. Volatile matter 135 °C (275 °F), not more than 0.3 percent. § 74.2710 D&C Yellow No. 10. Salt content (as NaC1), not more than 0.3 percent. (a) Identity and specifications. The Alcohol soluble matter, not more than 0.5 color additive D&C Yellow No. 10 shall percent. conform in identity and specifications Organic chlorine, not more than 0.5 percent.
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Aromatic amines, not more than 0.05 per- § 74.3106 D&C Blue No. 6. cent. Lead (as Pb), not more than 40 parts per mil- (a) Identity. The color additive D&C lion. Blue No. 6 is principally [∆2,2′- Arsenic (as As), not more than 3 parts per biindoline]-3,3′ dione (CAS Reg. No. million. 482–89–3). Mercury (as Hg), not more than 1 part per (b) Specifications. D&C Blue No. 6 million. shall conform to the following speci- Total color, not less than 98.5 percent. fications and shall be free from impuri- (c) Uses and restrictions. (1) The color ties other than those named to the ex- additive [phthalocyaninato(2-)] copper tent that such impurities may be may be safely used to color poly- avoided by good manufacturing prac- propylene sutures, polybutester (the tice: generic designation for the suture fab- Volatile matter at 135 °C (275 °F), not more ricated from 1,4-benzenedicarboxylic than 3 percent. acid, polymer with 1,4-butanediol and Matter insoluble in N,N- alpha-hydro-omega- hydroxypoly(oxy- dimethylformamide, not more than 1 per- 1,4-butanediyl), CAS Reg. No. 37282–12– cent. 5) nonabsorbable sutures for use in gen- Isatin, not more than 0.3 percent. eral and ophthalmic surgery, Anthranilic acid, not more than 0.3 percent. polybutylene terephthalate nonabsorb- Indirubin, not more than 1 percent. Lead (as Pb), not more than 10 parts per mil- able monofilament sutures for general lion. and ophthalmic surgery, and Arsenic (as As), not more than 3 parts per polymethylmethacrylate million. monofilament used as supporting Mercury (as Hg), not more than 1 part per haptics for intraocular lenses, subject million. to the following restrictions: Total color, not less than 95 percent. (i) The quantity of the color additive (c) Uses and restrictions. (1) D&C Blue does not exceed 0.5 percent by weight No. 6 may be safely used at a level— of the suture or haptic material. (i) Not to exceed 0.2 percent by (ii) The dyed suture shall conform in weight of the suture material for color- all respects to the requirements of the ing polyethylene terephthalate sur- U.S. Pharmacopeia. gical sutures for general surgical use; (2) The color additive (ii) Not to exceed 0.25 percent by [phthalocyaninato(2-)] copper may be weight of the suture material for color- safely used for coloring contact lenses ing plain or chromic collagen absorb- in amounts not to exceed the minimum able sutures for general surgical use; reasonably required to accomplish the (iii) Not to exceed 0.5 percent by intended coloring effect. weight of the suture material for color- (3) Authorization for these uses shall ing plain or chromic collagen absorb- not be construed as waiving any of the able sutures for ophthalmic surgical requirements of section 510(k), 515, or use; 520(g) the Federal Food, Drug, and Cos- (iv) Not to exceed 0.5 percent by metic Act with respect to the medical weight of the suture material for color- device in which [phthalocyaninato(2-)] ing polypropylene surgical sutures for copper is used. general surgical use; and (d) Labeling. The label of the color ad- (v) Not to exceed 0.5 percent by ditive shall conform to the require- weight of the suture material for color- ments of § 70.25 of this chapter. ing polydioxanone synthetic absorbable (e) Certification. All batches of sutures for ophthalmic and general sur- [phthalocyaninato (2-)] copper shall be gical use. certified in accordance with regula- (2) Authorization for these uses shall tions in part 80 of this chapter. not be construed as waiving any of the requirements of sections 510(k), 515, [48 FR 34947, Aug. 2, 1983, as amended at 50 FR 16228, Apr. 25, 1985; 51 FR 22929, June 24, and 520(g) of the Federal Food, Drug, 1986; 51 FR 28930, Aug. 13, 1986; 51 FR 39371, and Cosmetic Act with respect to the Oct. 28, 1986; 52 FR 15945, May 1, 1987; 55 FR medical device in which the color addi- 19620, May 10, 1990] tive is used.
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(d) Labeling. The label of the color ad- medical device in which D&C Green No. ditive shall conform to the require- 6 is used. ments of § 70.25 of this chapter. (d) Labeling. The label of the color ad- (e) Certification. All batches of D&C ditive shall conform to the require- Blue No. 6 shall be certified in accord- ments of § 70.25 of this chapter. ance with regulations in part 80 of this (e) Certification. All batches of D&C chapter. Green No. 6 shall be certified in accord- ance with regulations in part 80 of this [49 FR 29956, July 25, 1984; 49 FR 34447, Aug. chapter. 31, 1984, as amended at 50 FR 30698, July 29, 1985] [48 FR 13022, Mar. 29, 1983, as amended at 51 FR 9784, Mar. 21, 1986; 51 FR 37909, Oct. 27, § 74.3206 D&C Green No. 6. 1986; 58 FR 21542, Apr. 22, 1993] (a) Identity. The color additive D&C § 74.3230 D&C Red No. 17. Green No. 6 shall conform in identity to the requirements of § 74.1206(a). (a) Identity and specifications. The (b) Specifications. The color additive color additive D&C Red No. 17 shall D&C Green No. 6 for use in medical de- conform in identity and specifications vices shall conform to the specifica- to the requirements of § 74.1317(a)(1) tions of § 74.1206(b). and (b). (c) Uses and restrictions. (1) The color (b) Uses and restrictions. (1) The sub- additive D&C Green No. 6 may be safe- stance listed in paragraph (a) of this ly used at a level section may be used as a color additive (i) Not to exceed 0.03 percent by in contact lens in amounts not to ex- weight of the lens material for coloring ceed the minimum reasonably required contact lenses; to accomplish the intended coloring ef- (ii) Not to exceed 0.75 percent by fect. weight of the suture material for color- (2) Authorization for this use shall ing polyethylene terephthalate sur- not be construed as waiving any of the gical sutures, including sutures for requirements of section 510(k), 515, and ophthalmic use; 520(g) of the Federal Food, Drug, and (iii) Not to exceed 0.1 percent by Cosmetic Act with respect to the con- weight of the suture material for color- tact lens in which the color additive is ing polyglycolic acid surgical sutures used. with diameter greater than U.S.P. size (c) Labeling. The label of the color ad- 8–0, including sutures for ophthalmic ditive shall conform to the require- use; ments of § 70.25 of this chapter. (iv) Not to exceed 0.5 percent by (d) Certification. All batches of D&C weight of the suture material for color- Red No. 17 shall be certified in accord- ing polyglycolic acid surgical sutures ance with regulations in part 80 of this with diameter not greater than U.S.P. chapter. size 8–0, including sutures for oph- [55 FR 22898, June 5, 1990] thalmic use; (v) Not to exceed 0.21 percent by § 74.3602 D&C Violet No. 2. weight of the suture material for color- (a) Identity and specifications. The ing poly(glycolic acid-co-trimethylene color additive D&C Violet No. 2 shall carbonate) sutures (also referred to as conform in identity and specifications 1,4-dioxan-2,5-dione polymer with 1,3- to the requirements of § 74.1602(a)(1) dioxan-2-one) for general surgical use; and (b). and (b) Uses and restrictions. (1) The color (vi) Not to exceed 0.10 percent by additive, D&C Violet No. 2, may be weight of the haptic material for color- safely used for coloring contact lenses ing polymethylmethacrylate support in amounts not to exceed the minimum haptics of intraocular lenses. reasonably required to accomplish the (2) Authorization for these uses shall intended coloring effect. not be construed as waiving any of the (2) D&C Violet No. 2 may be safely requirements of sections 510(k), 515, used for coloring sutures for use in sur- and 520(g) of the Federal Food, Drug, gery subject to the following condi- and Cosmetic Act with respect to the tions:
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(i) At a level not to exceed 0.2 percent (b) Specifications. The color additive by weight of the suture material for D&C Yellow No. 10 for use in contact coloring polyglactin 910 (glycolic-lactic lenses shall conform to the specifica- acid polyester) synthetic absorbable tions of § 74.1710(b). sutures for use in general and oph- (c) Uses and restrictions. (1) The color thalmic surgery; and additive D&C Yellow No. 10 may be (ii) At a level not to exceed 0.3 per- used for coloring contact lenses in cent by weight of the suture material amounts not to exceed the minimum for coloring polydioxanone synthetic reasonably required to accomplish the absorbable sutures for use in general intended coloring effect. and ophthalmic surgery. (2) Authorization for this use shall (iii) At a level not to exceed 0.25 per- not be construed as waiving any of the cent by weight of the suture material requirements of sections 510(k), 515, for coloring poliglecaprone 25 (ε- and 520(g) of the Federal Food, Drug, caprolactone/glycolide copolymer) syn- and Cosmetic Act with respect to the thetic absorbable sutures for use in contact lens in which the color addi- general surgery. tive is used. (iv) At a level not to exceed 0.1 per- (d) Labeling. The label of the color ad- cent by weight of the suture material ditive shall conform to the require- for coloring poly(ε-caprolactone) ab- ments of § 70.25 of this chapter. sorbable sutures for use in general sur- (e) Certification. All batches of D&C gery. Yellow No. 10 shall be certified in ac- (v) At a level not to exceed 0.2 per- cordance with regulations in part 80 of cent by weight of the suture material this chapter. for coloring glycolide/dioxanone/ [52 FR 28690, Aug. 3, 1987] trimethylene carbonate tripolymer ab- sorbable sutures for use in general sur- APPENDIX A TO PART 74—THE PROCE- gery. DURE FOR DETERMINING ETHER (3) The color additive, D&C Violet SOLUBLE MATERIAL IN D&C RED No. 2, may be safely used for coloring NOS. 6 AND 7 polymethylmethacrylate intraocular lens haptics at a level not to exceed 0.2 The dye is dissolved in glacial acetic and 8 percent by weight of the haptic mate- N hydrochloric acids (1.33 : 1) and extracted with diethyl ether. Sulfonated moieties, in- rial. cluding the color additive, are discarded in (4) Authorization for these uses shall subsequent aqueous extractions of the ether. not be construed as waiving any of the Carboxylated moieties are removed from the requirements of sections 510(k), 515, ether by extraction with 2% (w/w) NaOH. The and 520(g) of the Federal Food, Drug, ether is evaporated to near dryness, ethanol and Cosmetic Act with respect to the (95%) is added, and the solution is analyzed medical devices in which the color ad- spectrophotometrically in the visible range. The absorbance at each wavelength must not ditive is used. exceed 150% of the absorbance similarly ob- (c) Labeling. The label of the color ad- tained for D&C Red No. 6 Lot AA5169. ditive shall conform to the require- ments of § 70.25 of this chapter. APPARATUS (d) Certification. All batches of D&C (A) Spectrophotometer (Cary 118 or equiva- Violet No. 2 shall be certified in ac- lent). cordance with regulations in part 80 of (B) Separatory funnels—one 1000 mL and this chapter. one 500 mL. [52 FR 19722, May 27, 1987, as amended at 55 REAGENTS FR 18868, May 7, 1990; 58 FR 60109, Nov. 15, NOTE: Use distilled water when water is re- 1993; 59 FR 11720, Mar. 14, 1994] quired. [42 FR 15654, Mar. 22, 1977, as amended at 63 (A) Glacial Acetic Acid (ACS grade). FR 20098, Apr. 23, 1998] (B) Diethyl ether (Anhydrous)—Note and follow safety precautions on container. § 74.3710 D&C Yellow No. 10. (C) 8 N HCl—Pour 165 mL H2O into a 500 mL graduate. Place the graduate in hood, then (a) Identity. The color additive D&C add HCl conc. to bring to volume. Carefully Yellow No. 10 shall conform to the pour this solution into a 500 mL Erlenmeyer identity requirements of § 74.1710(a). flask, Stopper and shake. Label the flask.
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(D) 2% (w/w) NaOH—Pour ca 190 mL H2O Shake the ether layer twice more with 100 into a 250 mL mixing graduate. Add 8 g. (5.23 mL portions of H2 O, discarding the bottom mL) of 50% (w/w) NaOH, bring to 200 mL vol- aqueous layer after each separation. ume with water, stopper and mix. Pour this Remove the unsulfonated subsidiary color solution into a glass bottle, label and stopper from the ether by shaking the ether layer for with a polytetrafluoroethylene top. one minute with 20 mL of 2% (w/w) NaOH. (E) Ethanol (95%). Appropriately label a 100 mL beaker. After the layers separate, drain the aqueous alkaline PROCEDURE layer into the beaker and save for the deter- Weigh a 250 mL beaker to tenths of a mg mination of 3-hydroxy-4-[(4-methylphenyl) and add 100 mg of dye. Record weight to azo]-2-naphthalenecarboxylic acid, sodium tenths of a mg. salt. If there is any color left in the ether, shake NOTE: The following work must be per- for one minute with another 20 mL portion formed in the hood. of 2% (w/w) NaOH. After the layers have sep- Add 75 mL of 8 HCl and 100 mL of glacial N arated, drain off the aqueous alkaline layer acetic acid to the beaker and stir. into the 100 mL beaker. Place the beaker on a hot plate and heat If color remains in the ether layer, repeat with stirring, until all of the dye is in solu- the above step for a total of three washes of tion. the ether with 2% (w/w) NaOH. Note: Three Remove the beaker from the hot plate, washes is usually sufficient to remove the cover with a watch glass and allow to cool to unsulfonated subsidiary. room temperature (1–2 hrs). With the stopper removed, gently swirl the When the dye solution is at room tempera- ether layer in the sep. funnel twice to sepa- ture, transfer the solution to a 1000 mL sepa- rate the remaining aqueous base. Drain this ratory funnel. into the 100 mL beaker. Rinse the beaker three times with 50 mL Appropriately label a 250 mL beaker. Pour portions of H2O, transferring each rinse to the ether layer into the beaker. Allow the the 1000 mL funnel. ether to evaporate to near dryness. Cool to Add 150 mL of ether to the funnel, stopper room temperature. Add ca 8 mL ethanol and shake for 10 seconds, then invert funnel (95%). Swirl beaker to mix contents. Quan- and open stopcock to remove gas buildup. titatively transfer to a 25 mL graduate using Shake the funnel for one minute, opening ethanol (95%) rinses. Add ethanol (95%) to the stopcock a few times while the funnel is bring volume to 15 mL. inverted to remove gas buildup. (Use this shake procedure throughout method.) SPECTROPHOTOMETRIC ANALYSIS Allow the funnel to stand until the layers Spectrophotometer Parameters: have separated. Scan Range: 400–700 nm Transfer the bottom (aqueous) layer to a Scan: 50 nm/in; 5.0 nm/sec. 500 mL separatory funnel, add 100 mL of Absorbance Range: 0–1 AUFS ether, stopper and shake for one minute. Cell length: 1 cm (Note: Reference and Sam- When the layers have separated, drain off ple cells) the bottom layer into a waste beaker. (1) Record the visible spectrum of a blank. Pour the ether layer in the 500 mL sepa- Fill the reference cell with distilled water ratory funnel into the 1000 mL separatory and the sample cell with ethanol (95%). funnel. (2) Rinse the sample cell with 2–3 mL of the Rinse the 500 mL sep. funnel with 100 mL ether soluble material (in ethanol solution); H2 O, then transfer it to the 1000 mL sep. fun- then fill the cell. Record the visible spec- nel, stopper and shake for one minute. trum of the ether soluble material. When the layers have separated, drain off (3) Compare the spectra obtained to the the bottom aqueous layer into the waste spectra attached. The attached spectra rep- beaker. resents 150% of the absorbance at each wave- Rinse the 500 mL funnel at least three length for similarly analyzed D&C Red No. 6 times (total) and repeat the 100 mL water Lot AA5169. washes until no color is present in the aque- The spectra of the current sample must ous layer. Discard the bottom aqueous layer not exceed the attached spectra at any wave- to the waste beaker after each separation. length in order to pass test.
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[47 FR 57688, Dec. 28, 1982; 48 FR 3946, Jan. 28, 1983; 48 FR 7438, Feb. 22, 1983; 48 FR 10811, Mar. 15, 1983]
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