Bacitracin Zinc and Polymyxin B Sulfate 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 Zinc and Polymyxin B Sulfate Ophthalmic Ointment contains the equivalent of NLT 90.0% and NMT 130.0% of the labeled amounts of bacitracin and polymyxin B.
2 IDENTIFICATION
A. THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST (201BNP): Meets the requirements
3 ASSAY
3.1 BACITRACIN
(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 Ophthalmic Ointment.
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 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.
Acceptance criteria: 90.0%-130.0%
3.2 POLYMYXIN B
(See Antibiotics-Microbial Assays (81).)
Sample solution: Shake a portion of Ophthalmic Ointment with about 50 mL of ether in a separator, and extract with four 20-mL portions of Buffer B.6 (see the chapter). Combine the buffer extracts, and dilute with Buffer B.6 to a suitable volume.
Analysis: Proceed as directed in the chapter. Dilute the Sample solution with Buffer B.6 to obtain a Test Dilution having a polymyxin B concentration that is nominally equivalent to the median level of the standard.
Acceptance criteria: 90.0%-130.0%
4 SPECIFIC TESTS
STERILITY TESTs (71): Meets the requirements
OTHER REQUIREMENTS: It meets the requirements for Particulate and Foreign Matter and Container Contents in Ophthalmic Products-Quality Tests
(771), Drug Product Quality, Universal Tests, Particulate and Foreign Matter and Container Contents
5 ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Preserve in collapsible ophthalmic ointment tubes. Store at controlled room temperature.
USP REFERENCE STANDARDS (11)
USP Bacitracin Zinc BS
USP Polymyxin B Sulfate RS
