Neomycin Sulfate and Triamcinolone Acetonide Cream
»Neomycin Sulfate and Triamcinolone Acetonide Cream contains the equivalent of not less than 90.0percent and not more than 135.0percent of the labeled amount of neomycin,and not less than 90.0percent and not more than 110.0percent of the labeled amount of triamcinolone acetonide (C24H34FO6).
Packaging and storage— Preserve in collapsible tubes or in tight containers.
Identification—
A: It meets the requirements for neomycin under Thin-Layer Chromatographic Identification Test á201BNPñ.
B: Place 2g of Cream in a conical flask,add 5.0mLof chloroform,and shake for 10minutes.Add 15mLof alcohol,and shake for an additional 10minutes.Filter the solution into a centrifuge tube,and evaporate the filtrate to dryness.Dissolve the residue in alcohol to obtain a solution containing about 250µg of triamcinolone acetonide per mL.Proceed as directed in the Identificationtest under Triamcinolone Acetonide Cream,beginning with “Apply 10µLof this solution”:the specified result is observed.
Minimum fill á755ñ: meets the requirements.
Assay for neomycin— Proceed with Cream as directed in the Assayunder Neomycin Sulfate Cream.
Assay for triamcinolone acetonide— Proceed with Cream as directed in the Assayunder Triamcinolone Acetonide Cream.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1364
Pharmacopeial Forum:Volume No.28(4)Page 1165
Phone Number:1-301-816-8335