Neomycin 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
Neomycin Sulfate Ophthalmic Ointment is a sterile preparation of Neomycin Sulfate in a suitable ointment base. It contains the equivalent of NLT 90.0% and NMT 135.0% of the labeled amount of neomycin.
2 IDENTIFICATION
A. THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST (201BNP): Meets the requirements
3 ASSAY
PROCEDURE
(See Antibiotics-Microbial Assays (81).)
Sample solution: Shake a portion of the Ophthalmic Ointment containing nominally 3.5 mg of neomycin 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%-135.0%
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
