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Food and Drug Administration, HHS § 436.101

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Food and Drug Administration, HHS § 436.101 Food and Drug Administration, HHS § 436.101 uninoculated broth prepared as de- Monobasic potassium phosphate: 80.0 gm. scribed in the applicable method for Distilled water, q.s: 1,000.0 ml. the antibiotic being assayed. Adjust with 18N phosphoric acid or [39 FR 18944, May 30, 1974, as amended at 41 10N potassium hydroxide to yield a pH FR 34743, Aug. 17, 1976] 5.95 to 6.05 after sterilization. (7)±(9) [Reserved] § 436.101 Solutions. (10) Solution 10 (0.2M potassium phos- (a) Antibiotic assay solutions are phate buffer, pH 10.5). prepared as follows (solution numbers Dibasic potassium phosphate: 35.0 gm. 1, 2, 3, 4, and 6 correspond to those used 10 N potassium hydroxide: 2.0 ml. in ``Assay Methods of Antibiotics,'' D. Distilled water, q.s: 1,000.0 ml. C. Grove and W. A. Randall, Medical Adjust with 18N phosphoric acid or Encyclopedia, Inc., New York, N.Y. 10N potassium hydroxide to yield a pH (1955), p. 222), which is incorporated by 10.4 to 10.6 after sterilization. reference. Copies are available from (11) Solution 11 (10 percent potassium the Medical Encyclopedia Inc., 30 East phosphate buffer, pH 2.5). 60th St., New York, NY 11220, or avail- able for inspection at the Office of the Monobasic potassium phosphate: 100.0 gm. Federal Register, 800 North Capitol Concentrated hydrochloric acid: 0.2 ml. (ap- Street, NW., suite 700, Washington, DC. proximately). Distilled water, q.s: 1,000.0 ml. (1) Solution 1 (1 percent potassium phosphate buffer, pH 6.0). Adjust with 18N phosphoric acid or 10N potassium hydroxide to yield a pH Dibasic potassium phosphate: 2.0 gm. Monobasic potassium phosphate: 8.0 gm. 2.0 to 2.8 after sterilization. Distilled water, q.s: 1,000.0 ml. (12) Solution 12 (10 percent potassium phosphate buffer, pH 7.0). Adjust with 18N phosphoric acid or 10N potassium hydroxide to yield a pH Monobasic potassium phosphate: 100.0 gm. 5.95 to 6.05 after sterilization. Distilled water, q.s: 1,000.0 ml. (2) Solution 2 (citrate buffer solution pH Adjust with 18N phosphoric acid or 6.3). 10N potassium hydroxide to yield a pH Citric acid: 13.2 gm. 6.95 to 7.05 after sterilization. Sodium hydroxide: 7.06 gm. (13) Solution 13 (0.01N methanolic hy- Sodium citrate: 97.0 gm. drochloric acid). Distilled water, q.s: 1,000.0 ml. 1.0N hydrochloric acid: 10.0 ml. Adjust with 10 percent citric acid so- Methyl alcohol, q.s: 1,000.0 ml. lution or 10N sodium hydroxide to yield (14) Solution 14 (2 percent sodium bicar- pH 6.2 to 6.4 after sterilization. bonate solution). (3) Solution 3 (0.1M potassium phos- phate buffer, pH 8.0). Sodium bicarbonate: 20.0 gm. Distilled water, q.s: 1,000.0 ml. Dibasic potassium phosphate: 16.73 gm. Monobasic potassium phosphate: 0.523 gm. Prepare daily. Distilled water, q.s: 1,000.0 ml. (15) Solution 15 (80 percent isopropyl al- Adjust with 18N phosphoric acid or cohol solution). 10N potassium hydroxide to yield a pH Isopropyl alcohol: 800.0 ml. 7.9 to 8.1 after sterilization. Distilled water, q.s: 1,000.0 ml. (4) ( Solution 4 0.1M potassium phosphate (16) Solution 16 (0.1 M potassium phos- ). buffer, pH 4.5 phate buffer, pH 7.0). Monobasic potassium phosphate: 13.6 gm. Dibasic potassium phosphate: 13.6 gm. Distilled water, q.s: 1,000.0 ml. Monobasic potassium phosphate: 4.0 gm. Adjust with 18N phosphoric acid or Distilled water, q.s.: 1,000.0 ml. 10N potassium hydroxide to yield a pH Adjust with 18 N phosphoric acid or 4.45 to 4.55 after sterilization. 10 N potassium hydroxide to yield a pH (5) [Reserved] 6.8 to 7.2 after sterilization. (6) Solution 6 (10 percent potassium (17) Solution 17 (5 percent methyl alco- phosphate buffer, pH 6.0). hol in 1 percent potassium phosphate Dibasic potassium phosphate: 20.0 gm. buffer, pH 6.0). 361 VerDate 09<APR>98 09:55 Apr 16, 1998 Jkt 179070 PO 00000 Frm 00355 Fmt 8010 Sfmt 8010 Y:\SGML\179070.TXT 179070-3 § 436.102 21 CFR Ch. I (4±1±98 Edition) Methyl alcohol: 50.0 ml. Dextrose: 1.0 gm. 1 percent potassium phosphate buffer, pH 6.0, Agar: 15.0 gm. q.s.: 1,000.0 ml. Distilled water, q.s: 1,000.0 ml. pH 6.5 to 6.6 after sterilization. (18) Solution 18 (0.054M sodium phos- phate buffer, pH 6.9). (2) Medium 2. Sodium dihydrogen phosphate Peptone: 6.0 gm. monohydrate: 3.97 gm. Yeast extract: 3.0 gm. Disodium hydrogen phosphate anhydrous: Beef extract: 1.5 gm. 3.55 gm. Agar: 15.0 gm. Distilled water, q.s.: 1,000.0 mL. Distilled water, q.s: 1,000.0 ml. pH 6.5 to 6.6 after sterilization. [39 FR 18944, May 30, 1974, as amended at 40 FR 52004, Nov. 7, 1975; 45 FR 75194, Nov. 14, (3) Medium 3. 1980; 47 FR 9396, Mar. 5, 1982] Peptone: 5.0 gm. § 436.102 Culture media. Yeast extract: 1.5 gm. Beef extract: 1.5 gm. (a) Ingredients. Use ingredients that Sodium chloride: 3.5 gm. conform to the standards, if any, pre- Dextrose: 1.0 gm. scribed by the U.S.P. or N.F. In lieu of Dipotassium phosphate: 3.68 gm. preparing the media from the individ- Potassium dihydrogen phosphate: 1.32 gm. ual ingredients specified, they may be Distilled water, q.s: 1,000.0 ml. made from dehydrated mixtures that, pH 6.95 to 7.05 after sterilization. when reconstituted with distilled (4) Medium 4. water, have the same composition as Peptone: 6.0 gm. such media. Minor modifications of the Yeast extract: 3.0 gm. individual ingredients specified in this Beef extract: 1.5 gm. section are permissible if the resulting Dextrose: 1.0 gm. media possess growth-promoting prop- Agar: 15.0 gm. erties at least equal to the media de- Distilled water, q.s: 1,000.0 ml. scribed. pH 6.5 to 6.6 after sterilization. (b) Description of media. Medium num- (5) Medium 5. Medium 5 is the same as bers 1, 2, 3, 4, 5, 8, 9, 10, 11, and 13 cor- medium 2, except adjust the final pH to respond to those used in ``Assay Meth- 7.8 to 8.0 after sterilization. ods of Antibiotics,'' D. C. Grove and W. (6)±(7) [Reserved] A. Randall, Medical Encyclopedia, Inc., (8) Medium 8. Medium 8 is the same as New York, N.Y. (1955) p. 220, which is medium 2, except adjust the final pH to incorporated by reference. Copies are 5.8 to 6.0 after sterilization. available from Medical Encyclopedia (9) Medium 9. Inc., 30 East 60th St., New York, NY, or available for inspection at the Office of Pancreatic digest of casein: 17.0 gm. Papaic digest of soybean: 3.0 gm. the Federal Register, 800 North Capitol Sodium chloride: 5.0 gm. Street, NW., suite 700, Washington, DC. Dipotassium phosphate: 2.5 gm. Medium numbers 18 through 21 cor- Dextrose: 2.5 gm. respond to those used in ``Outline of Agar: 20.0 gm. Details for Official Microbiological As- Distilled water, q.s: 1,000.0 ml. says of Antibiotics,'' A. Kirshbaum and pH 7.2 to 7.3 after sterilization. B. Arret, ``Journal of Pharmaceutical (10) Medium 10. Medium 10 is the same Sciences,'' vol. 56, No. 4, April 1967, p. as medium 9, except: 512, which is incorporated by reference. Copies are available from the American Agar: 12.0 gm. Polysorbate 80 (add polysorbate 80 after boil- Pharmaceutical Association, 2215 Con- ing the medium to dissolve the agar): 10.0 stitution Ave. NW., Washington, DC ml. 20037, or available for inspection at the pH 7.2 to 7.3 after sterilization. Office of the Federal Register (see ad- dress in this paragraph). (11) Medium 11. Medium 11 is the same (1) Medium 1. as medium 1, except adjust the final pH to 7.8 to 8.0 after sterilization. Peptone: 6.0 gm. (12) [Reserved] Pancreatic digest of casein: 4.0 gm. (13) Medium 13. Yeast extract: 3.0 gm. Beef extract: 1.5 gm. Peptone: 10.0 gm. 362 VerDate 09<APR>98 09:55 Apr 16, 1998 Jkt 179070 PO 00000 Frm 00356 Fmt 8010 Sfmt 8010 Y:\SGML\179070.TXT 179070-3.
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