Bacitracin Ophthalmic 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 Ophthalmic Ointment is a sterile preparation of Bacitracin 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))
Sample solution: Use a portion of Ophthalmic Ointment shaken with about 50 mL of ether in a separator and extracted with four 20-mL portions of Buffer B.1 (see the chapter). Combine the buffer extracts, and dilute with Buffer B.1 to a suitable volume.
Analysis: Proceed as directed in the chapter. Add sufficient 0.01 N hydrochloric acid to a suitable aliquot of the Sample solution so that the amount of hydrochloric acid in the Test Dilution is the same as in the median level of the standard. Dilute with Buffer B.1 to obtain a Test Dilution having a bacitracin concentration that is nominally equivalent to the median level of the standard.
Acceptance criteria: 90.0%-140.0%
4 SPECIFIC TESTS
STERILITY TESTS (71): Meets the requirements
OTHER REQUIREMENTS: It meets the requirements for Particulate and Foreign Matter in Ophthalmic Products-Quality Tests (771), Drug Product Quality. Universal Tests. Particulate and Foreign Matter.
5 ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Preserve in collapsible ophthalmic ointment tubes. Store at controlled room temperature.
USP REFERENCE STANDARDS (11)
USP Bacitracin Zinc RS
