» Bacitracin Ointment is Bacitracin in an anhydrous ointment base. It contains not less than 90.0 percent and not more than 140.0 percent of the labeled amount of bacitracin. It may contain a suitable anesthetic.
Packaging and storage Preserve in well-closed containers containing not more than 60 g, unless labeled solely for hospital use, preferably at controlled room temperature.
USP Reference standards 11
USP Bacitracin Zinc RS
Thin-layer chromatographic identification test 201BNP: meets the requirements.
Minimum fill 755: meets the requirements.
Water, Method I 921: not more than 0.5%, 20 mL of a mixture of toluene and methanol (7:3) being used in place of methanol in the titration vessel.
Assay Proceed as directed under AntibioticsMicrobial Assays 81, using an accurately weighed portion of Ointment shaken with about 50 mL of ether in a separator, and extracted with four 20-mL portions of Buffer No. 1. Combine the buffer extracts, and dilute with Buffer No. 1 to an appropriate volume to obtain a stock solution. Add sufficient 0.01 N hydrochloric acid to an accurately measured portion of the stock solution so that the amount of hydrochloric acid in the Test Dilution will be the same as in the median dose level of the Standard, and quantitatively dilute with Buffer No. 1 to obtain a Test Dilution having a bacitracin concentration assumed to be equal to the median dose level of the Standard.
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USP35NF30 Page 2296Pharmacopeial Forum: Volume No. 28(4) Page 1070