Neomycin and Polymyxin B Sulfates 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 Ophthalmic Ointment is a sterile ointment containing Neomycin Sulfate and Polymyxin B Sulfate. It contains the equivalent of NLT 90.0% and NMT 130.0% of the labeled amounts of neomycin and polymyxin B.
2 IDENTIFICATION
A. Thin-Layer Chromatographic Identification Test 〈201BNP〉: Meets the requirements
3 ASSAY
3.1 Neomycin
(See Antibiotics-Microbial Assays 〈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%–130.0%
3.2 Polymyxin B
(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 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%–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.
USP Reference Standards 〈11〉
USP Neomycin Sulfate RS
USP Polymyxin B Sulfate RS
