Pt. 452 21 CFR Ch. I (4±1±96 Edition) hypodermic needle and syringe, remove 452.110b Erythromycin enteric-coated tab- all of the withdrawable contents from lets. each container if it is represented as a 452.110c Erythromycin capsules. single dose container; or if the labeling 452.110d Erythromycin particles in tablets. specifies the amount of potency in a 452.115 Erythromycin estolate oral dosage given volume of the resultant prepara- forms. tion, remove an accurately measured 452.115a Erythromycin estolate tablets. representative portion from each con- 452.115b Erythromycin estolate capsules. tainer. Dilute the solution thus ob- 452.115c Erythromycin estolate oral suspen- sion. tained with sufficient 1 percent potas- 452.115d Erythromycin estolate for oral sus- sium phosphate buffer, pH 6.0 (solution pension. 1), to give a stock solution of conven- 452.115e Erythromycin estolate for pediatric ient concentration. Further dilute the drops. stock solution with solution 1 to the 452.115f Erythromycin estolate chewable reference concentration of 1 microgram tablets. of mitomycin per milliliter (esti- 452.115g Erythromycin estolate and mated). sulfisoxazole acetyl oral suspension. (2) Sterility. Proceed as directed in 452.125 Erythromycin ethylsuccinate oral § 436.20 of this chapter, using the meth- dosage forms. od described in paragraph (e)(1) of that 452.125a Erythromycin ethylsuccinate section. chewable tablets. (3) Pyrogens. Proceed as directed in 452.125b Erythromycin ethylsuccinate oral suspension. § 436.32(a) of this chapter, using a solu- 452.125c Erythromycin ethylsuccinate for tion containing 0.5 milligram of oral suspension. mitomycin per milliliter. 452.125d Erythromycin ethylsuccinate tab- (4) [Reserved] lets. (5) Depressor substances. Proceed as 452.125e Erythromycin ethylsuccinate- directed in § 436.35 of this chapter. sulfisoxazole acetyl for oral suspension. (6) Moisture. Proceed as directed in 452.135 Erythromycin stearate oral dosage § 436.201 of this chapter. forms. (7) pH. Proceed as directed in § 436.202 452.135a Erythromycin stearate tablets. of this chapter using the drug reconsti- 452.135b Erythromycin stearate oral suspen- tuted as directed in the labeling. sion. (8) Identity. Proceed as directed in 452.135c Erythromycin stearate for oral sus- § 436.310 of this chapter. pension. 452.150 Clarithromycin tablets. [39 FR 19145, May 30, 1974, as amended at 46 452.160 Azithromycin oral dosage forms. FR 60568, Dec. 11, 1981; 50 FR 19920, May 13, 452.160a Azithromycin capsules. 1985] 452.160b Azithromycin for oral suspension. 452.175 Troleandomycin oral dosage forms. PART 452ÐMACROLIDE ANTIBIOTIC 452.175a Troleandomycin capsules. DRUGS 452.175b Troleandomycin oral suspension. 452.175c Troleandomycin for oral suspen- Subpart AÐBulk Drugs sion. 452.175d Troleandomycin chewable tablets. Sec. 452.10 Erythromycin. Subpart CÐInjectable Dosage Forms 452.15 Erythromycin estolate. 452.25 Erythromycin ethylsuccinate. 452.225 Erythromycin ethylsuccinate injec- 452.25a Sterile erythromycin tion. ethylsuccinate. 452.230 Sterile erythromycin gluceptate. 452.30a Sterile erythromycin gluceptate. 452.232 Erythromycin lactobionate 452.32a Sterile erythromycin lactobionate. injectable dosage forms. 452.35 Erythromycin stearate. 452.232a Erythromycin lactobionate for in- 452.50 Clarithromycin. jection. 452.60 Azithromycin. 452.75 Troleandomycin. 452.232b Sterile erythromycin lactobionate. Subpart BÐOral Dosage Forms Subpart DÐOphthalmic Dosage Forms 452.110 Erythromycin oral dosage forms. 452.310 Erythromycin ophthalmic ointment. 452.110a Erythromycin tablets. 920 VerDate 17<JUL>96 11:55 Jul 29, 1996 Jkt 167069 PO 00000 Frm 00915 Fmt 8010 Sfmt 8010 C:\CFR\21V5.001 pfrm13 Food and Drug Administration, HHS § 452.15 Subpart EÐ[Reserved] ignition, heavy metals, pH, identity, and crystallinity. Subpart FÐDermatologic Dosage Forms (ii) Samples required: 10 packages, 452.510 Erythromycin dermatologic dosage each containing not less than 500 milli- forms. grams. 452.510a Erythromycin ointment. (b) Tests and methods of assayÐ(1) Po- 452.510b Erythromycin topical solution. tency. Proceed as directed in § 436.105 of 452.510d Erythromycin-benzoyl peroxide topical gel. this chapter, preparing the sample for 452.510e Erythromycin topical gel. assay as follows: Dissolve an accu- rately weighed sample in sufficient Subpart GÐ[Reserved] methyl alcohol to give a concentration of 10 milligrams of erythromycin base Subpart HÐRectal Dosage Forms per milliliter (estimated). Dilute this 452.710 Erythromycin suppositories. solution further with sufficient 0.1M potassium phosphate buffer, pH 8.0 (so- Subpart IÐ[Reserved] lution 3), to give a stock solution con- taining 1.0 milligram of erythromycin Subpart JÐCertain Other Dosage Forms base per milliliter (estimated). Further 452.910 Erythromycin for prescription dilute an aliquot of the stock solution compounding. with solution 3 to the reference con- centration of 1.0 microgram of erythro- AUTHORITY: Sec. 507 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 357). mycin base per milliliter (estimated). (2) [Reserved] Subpart AÐBulk Drugs (3) Moisture. Proceed as directed in § 436.201 of this chapter. § 452.10 Erythromycin. (4) pH. Proceed as directed in § 436.202 (a) Requirements for certificationÐ(1) of this chapter, except standardize the Standards of identity, strength, quality, pH meter with pH 7.0 and pH 10.0 buff- and purity. Erythromycin is the odor- ers and prepare the sample as follows: less, white to grayish-white or slightly Dissolve 200 milligrams of sample in 5 yellow compound of a kind of erythro- milliliters of reagent grade methyl al- mycin or a mixture of two or more cohol. Add 95 milliliters of water and such compounds. It is so purified and mix. Record the pH when an equi- dried that: librium value has been reached. (i) It contains not less than 850 (5) Residue on ignition. Proceed as di- micrograms of erythromycin per milli- rected in § 436.207(a) of this chapter. gram calculated on an anhydrous basis. (6) Heavy metals. Proceed as directed (ii) [Reserved] in § 436.208 of this chapter. (iii) Its moisture content is not more (7) Crystallinity. Proceed as directed than 10 percent. in § 436.203(a) of this chapter. (iv) Its pH is not less than 8.0 or more (8) Identity test. Proceed as directed than 10.5. in § 436.211 of this chapter, using the (v) Its residue on ignition is not more sample preparation method described than 2.0 percent. in paragraph (b)(3) of that section. (vi) Its heavy metals content is not more than 50 parts per million. [39 FR 19149, May 30, 1974, as amended at 42 (vii) It gives a positive identity test FR 38564, July 29, 1977; 43 FR 9801, Mar. 10, for erythromycin. 1978; 50 FR 19920, May 13, 1985] (viii) It is crystalline. § 452.15 Erythromycin estolate. (2) Labeling. It shall be labeled in ac- cordance with the requirements of (a) Requirements for certificationÐ(1) § 432.5 of this chapter. Standards of identity, strength, quality, (3) Requests for certification; samples. and purity. Erythromycin estolate is In addition to the requirements of the lauryl sulfate salt of the propionyl § 431.1 of this chapter, each such re- ester of a kind of erythromycin or a quest shall contain: mixture of two or more such salts. It (i) Results of tests and assays on the occurs as a white powder. It is soluble batch for potency, moisture, residue on in alcohol, methyl alcohol, acetone, 921 VerDate 17<JUL>96 11:55 Jul 29, 1996 Jkt 167069 PO 00000 Frm 00916 Fmt 8010 Sfmt 8010 C:\CFR\21V5.001 pfrm13.