Pt. 448 21 CFR Ch. I (4±1±96 Edition) (ii) Samples required: Subpart HÐRectal Dosage Forms (a) The oxytetracycline hydro- [Reserved] chloride used in making the batch: 10 packages, each containing approxi- mately 300 milligrams. Subpart IÐ[Reserved] (b) The polymyxin B sulfate used in making the batch: 10 packages, each Subpart JÐCertain Other Dosage containing approximately 300 milli- Forms [Reserved] grams. (c) The batch: A minimum of 30 tab- PART 448ÐPEPTIDE ANTIBIOTIC lets. DRUGS (b) Tests and methods of assayÐ(1) Po- tencyÐ(i) Oxytetracycline content. Pro- Subpart AÐBulk Drugs ceed as directed in § 436.106 of this chap- ter, preparing the sample for assay as Sec. 448.10 Bacitracin. follows: Place a representative number 448.10a Sterile bacitracin. of tablets into a high-speed glass blend- 448.13 Bacitracin zinc. er jar containing sufficient 0.1N hydro- 448.13a Sterile bacitracin zinc. chloric acid to obtain a stock solution 448.15a Sterile capreomycin sulfate. of convenient concentration containing 448.20a Sterile colistimethate sodium. not less than 150 micrograms of oxytet- 448.21 Colistin sulfate. racycline per milliliter (estimated). 448.23 Cyclosporine. Blend for 3 to 5 minutes. Remove an al- 448.25 Gramicidin. iquot of the stock solution and further 448.30 Polymyxin B sulfate. dilute with sterile distilled water to 448.30a Sterile polymyxin B sulfate. the reference concentration of 0.24 448.75 Tyrothricin. microgram of oxytetracycline per mil- liliter (estimated). Subpart BÐOral Dosage Forms (ii) Polymyxin B content. Proceed as 448.121 Colistin sulfate for oral suspension. directed in § 436.105 of this chapter, pre- 448.123 Cyclosporine oral dosage forms. paring the sample for assay as follows: 448.123a Cyclosporine oral solution. Grind a representative number of tab- 448.123b Cyclosporine capsules. lets into a fine powder and place this powder, accurately weighed, into a fil- Subpart CÐInjectable Dosage Forms ter funnel with a solvent-resistant 448.210 Sterile bacitracin. membrane filter of 1.0 micrometer po- 448.215 Sterile capreomycin sulfate. rosity. Wash the powder with five 20- 448.220 Colistimethate sodium injectable milliliter portions of acetone or until dosage forms. the yellow color has disappeared. Re- 448.220a Sterile colistimethate sodium. move the filter and soak in 400 milli- 448.223 Cyclosporine for infusion. liters of 10 percent potassium phos- 448.230 Sterile polymyxin B sulfate. phate buffer, pH 6.0 (solution 6), and blend. Quantitatively transfer to a 500- Subpart DÐOphthalmic Dosage Forms milliliter volumetric flask and adjust 448.310 Bacitracin ophthalmic dosage forms. to volume with solution 6. Further di- 448.310a [Reserved] lute an aliquot with solution 6 to the 448.310b Bacitracin-neomycin sulfate- reference concentration of 10 units of polymyxin B sulfate ophthalmic oint- polymyxin B per milliliter (estimated). ment. (2) Loss on drying. Proceed as directed 448.310c Bacitracin ophthalmic ointment. in § 436.200(b) of this chapter. 448.313 Bacitracin zinc ophthalmic dosage forms. [43 FR 11174, Mar. 17, 1978, as amended at 50 448.313a Bacitracin zinc-polymyxin B sul- FR 19920, May 13, 1985] fate ophthalmic ointment. 834 VerDate 17<JUL>96 11:55 Jul 29, 1996 Jkt 167069 PO 00000 Frm 00829 Fmt 8010 Sfmt 8010 C:\CFR\21V5.001 pfrm13 Food and Drug Administration, HHS § 448.10 448.313b Bacitracin zinc-neomycin sulfate- SOURCE: 39 FR 19115, May 30, 1974, unless polymyxin B sulfate ophthalmic oint- otherwise noted. ment; bacitracin zinc-neomycin sulfate- polymyxin B sulfate hydrocortisone oph- thalmic ointment. Subpart AÐBulk Drugs 448.321 Colistin sulfate for ophthalmic solu- tion. § 448.10 Bacitracin. 448.330 Polymyxin B sulfate-trimethoprim (a) Requirements for certificationÐ (1) hemisulfate ophthalmic solution. Standards of identity, strength, quality, and purity. Bacitracin is a white to Subpart EÐOtic Dosage Forms brown, neutral water-soluble 448.421 Colistin sulfate-neomycin sulfate- polypeptide. It is so purified and dried thonzonium bromide-hydrocortisone ace- that: tate otic suspension. (i) Its potency is not less than 40 448.430 Polymyxin B sulfate-hydrocortisone units of bacitracin per milligram. otic solution. (ii) [Reserved] Subpart FÐDermatologic Dosage Forms (iii) Its loss on drying is not more than 5 percent. 448.510 Bacitracin dermatologic dosage (iv) Its pH in an aqueous solution forms. containing 10,000 units per milliliter is 448.510a Bacitracin ointment. not less than 5.5 and not more than 7.5. 448.510bÐ448.510c [Reserved] (v) It passes the identity test. 448.510d Bacitracin-neomycin sulfate oint- ment. (2) Labeling. It shall be labeled in ac- 448.510e Bacitracin±neomycin sulfate- cordance with the requirements of polymyxin B sulfate ointment. § 432.5 of this chapter. 448.510f Bacitracin-polymyxin B sulfate top- (3) Requests for certification; samples. ical aerosol. In addition to complying with the re- 448.513 Bacitracin zinc dermatologic dosage quirements of § 431.1 of this chapter, forms. each such request shall contain: 448.513a Bacitracin zinc-polymyxin B sul- fate ointment. (i) Results of tests and assays on the 448.513b Bacitracin zinc-neomycin sulfate batch for potency, loss on drying, pH, ointment. and identity. 448.513c Bacitracin zinc-neomycin sulfate- (ii) Samples required: 10 packages, polymysin B sulfate ointment; bacitracin each containing approximately 1.0 zinc-neomycin sulfate-polymyxin B sul- gram. fate hydrocortisone ointment. (b) Tests and methods of assayÐ(1) Po- 448.513d Bacitracin zinc-polymyxin B sul- fate topical powder. tency. Proceed as directed for baci- 448.513e Bacitracin zinc-polymyxin B sul- tracin zinc in § 436.105 of this chapter, fate topical aerosol. preparing the sample for assay as fol- 448.513f Bacitracin zinc ointment. lows: Dissolve an accurately weighed sample in sufficient 1.0 percent potas- Subpart GÐVaginal Dosage Forms sium phosphate buffer, pH 6.0 (solution [Reserved] 1), to obtain a stock solution of con- venient concentration. Remove an ali- Subparts H±IÐ[Reserved] quot of the stock solution, add suffi- cient hydrochloric acid so that the Subpart JÐCertain Other Dosage Forms amount of acid in the final solution 448.910 Bacitracin for prescription will be the same as in the reference compounding. concentration of the working standard 448.913 Bacitracin zinc for prescription and further dilute with solution 1 to compounding. the reference concentration of 1.0 unit 448.930 Polymyxin B sulfate in certain other of bacitracin per milliliter (estimated). dosage forms. 448.930a Polymyxin B sulfate for prescrip- (2) [Reserved] tion compounding. (3) Loss on drying. Proceed as directed 448.930b Sterile polymyxin B sulfate- in § 436.200(b) of this chapter. benzalkonium chloride urethral lubri- (4) pH. Proceed as directed in § 436.202 cant. of this chapter, using an aqueous solu- AUTHORITY: Sec. 507 of the Federal Food, tion containing 10,000 units per milli- Drug, and Cosmetic Act (21 U.S.C. 357). liter. 835 VerDate 17<JUL>96 11:55 Jul 29, 1996 Jkt 167069 PO 00000 Frm 00830 Fmt 8010 Sfmt 8010 C:\CFR\21V5.001 pfrm13.