U.S. PHARMACOPEIA

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Neomycin Sulfate Tablets
» 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.
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.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
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 No. 3 to obtain a stock solution having a convenient concentration. Dilute this stock solution quantitatively and stepwise with Buffer No. 3 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 1493
Pharmacopeial Forum : Volume No. 28(4) Page 1153
Phone Number : 1-301-816-8223