Neomycin and Polymyxin B Sulfates and 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
Neomycin and Polymyxin B Sulfates and Bacitracin Ophthalmic Ointment is a sterile ointment containing Neomycin Sulfate, Polymyxin B Sulfate, and Bacitracin. It contains the equivalent of NLT 90.0% and NMT 140.0% of the labeled amounts of neomycin, polymyxin B, and bacitracin.
2 IDENTIFICATION
A. THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST (201BNP); Meets the requirements
3 ASSAY
3.1 NEOMYCIN
(See Antibiotics-Microbial Assavs (81).)
Sample solution: Shake a portion of Ophthalmic Ointment in a separator with 50 mL of ether. Extract with four 20-mL portions of Buffer B.3.
Combine the aqueous extracts, and dilute with Buffer B.3 to a suitable volume.
Analysis: Proceed as directed in the chapter. Dilute the Sample solution with Buffer B.3 to obtain a Test Dilution having a neomycin concentration that is nominally equivalent to the median level of the standard.
Acceptance criteria: 90.0%-140.0%
3.2 POLYMYXIN B
(See Antibiotics-Microbial Assavs (81),)
Sample solution: Shake a portion of Ophthalmic Ointment with 50 ml, of ether in a separator. Extract with four 25-ml, portions of Buffer B.6.
Combine the aqueous 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 concentration that is nominally equivalent to the median level of the standard (10 Polymyxin B Units/mL). Add to each Test Dilution of the standard, a quantity of USP Neomycin Sulfate RS, dissolved in Buffer B.6, to obtain the same concentration of neomycin as in the Test Dilution of the sample.
Acceptance criteria: 90.0%-140.0%
3.3 BACITRACIN
(See Antibiotics-Microbial Assays (81).)
Sample solution: Shake a portion of Ophthalmic Ointment with 50 mL of ether in a separator. Extract with four 25-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 concentration that is. nominally equivalent to the median level of the standard (1.0 Bacitracin Unit/mL). If the Sample solution has a concentration of less than
100 Bacitracin Units/mL, add 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
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.
USP REFERENCE STANDARDS (11)
USP Bacitracin Zinc RS
USP Neumicin Sulfate RS
