Neomycin Sulfate Tablets
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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)
Neomycin Sulfate Tablets contain the equivalent of not less than 90.0 percent and not more than 125.0 percent of the labeled amount of neomycin.
Packaging and storage-Preserve in tight containers.
USP REFERENCE STANDARDS (11)
USP Neomycin Sulfate RS
THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST (201BNP)-
Test solution-Shake a portion of ground Tablet powder, equivalent to about 70 mg of neomycin (base), with 5 mL of water, and filter. Dilute a portion of this solution with 0.1 N hydrochloric acid to obtain a solution containing the equivalent of 3.5 mg of neomycin (base) per ml.. It meets the requirements.
DISINTEGRATION (701): 60 minutes.
UNIFORMITY OF DOSAGE UNITS (905): meet the requirements.
LOSS ON DRYING (731)-Dry about 100 mg of powdered Tablets, accurately weighed, in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5 mm of mercury at 60° for 3 hours: it loses not more than 10.0% of its weight.
Assay-Proceed as directed under Antibiotics-Microbial Assays (81), using not less than 5 Tablets blended at high-speed in a blender jar for 3 to 5 minutes with a sufficient accurately measured volume of Buffer B.3 to obtain a stock solution having a convenient concentration. Dilute this stock solution quantitatively and stepwise with Buffer B.3 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
