Bacitracin Zinc Ointment
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
1 DEFINITION
Bacitracin Zinc Ointment is Bacitracin Zinc in an anhydrous ointment base. It contains NLT 90.0% and NMT 140.0% of the labeled amount of bacitracin.
2 IDENTIFICATION
A. THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST (201BNP): Meets the requirements
3 ASSAY
PROCEDURE
(See Antibiotics-Microbial Assays (81).)
Standard solution: Proceed as directed in the chapter. To each Test Dilution of the standard add sufficient hydrochloric acid to obtain the same concentration of hydrochloric acid as in the Test Dilution of Ointment.
Sample solution: Use a portion of Ointment shaken with about 50 mL of ether in a separator and extracted with four 20-mL portions of 0.01 N hydrochloric acid. Combine the acid extracts, and dilute with 0.01 N hydrochloric acid to a suitable volume.
Analysis: Proceed as directed in the chapter. Dilute the Sample solution with Buffer B.1 to obtain a Test Dilution having a bacitracin concentration that is nominally equivalent to the median level of the standard. Add sufficient hydrochloric acid to each Test Dilution of the standard to obtain the same concentration of hydrochloric acid as in the Test Dilution of the sample.
Acceptance criteria: 90.0%-140.0%
4 SPECIFIC TESTS
WATER DETERMINATION, Method (921)
Analysis: Use 20 mL of a mixture of toluene and methanol (7:3) in place of methanol in the titration vessel.
Acceptance criteria: NMT 0.5%
MINIMUM FILL (755): Meets the requirements
5 ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Preserve in well-closed containers containing NMT 60 g, unless labeled solely for hospital use, preferably at controlled room temperature.
USP REFERENCE STANDARDS (11)
USP Bacitracın Zinc RS
