Neomycin Sulfate Tablets
»Neomycin Sulfate Tablets contain the equivalent of not less than 90.0percent and not more than 125.0percent of the labeled amount of neomycin.
Packaging and storage— Preserve in tight containers.
Thin-layer chromatographic identification test á201BNPñ—
Test solution— Shake a portion of ground Tablet powder,equivalent to about 70mg of neomycin (base),with 5mLof water,and filter.Dilute a portion of this solution with 0.1Nhydrochloric acid to obtain a solution containing the equivalent of 3.5mg of neomycin (base)per mL.It meets the requirements.
Uniformity of dosage units á905ñ: meet the requirements.
Loss on drying á731ñ— Dry about 100mg of powdered Tablets,accurately weighed,in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5mm of mercury at 60for 3hours:it loses not more than 10.0%of its weight.
Assay— Proceed as directed under Antibiotics—Microbial Assays á81ñ,using not less than 5Tablets blended at high-speed in a blender jar for 3to 5minutes with a sufficient accurately measured volume of Buffer No.3to obtain a stock solution having a convenient concentration.Dilute this stock solution quantitatively and stepwise with Buffer No.3to obtain a Test Dilutionhaving a concentration assumed to be equal to the median dose level of the Standard.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1344
Pharmacopeial Forum:Volume No.28(4)Page 1153
Phone Number:1-301-816-8335
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