Gentamicin Sulfate Cream
»Gentamicin Sulfate Cream contains the equivalent of not less than 90.0percent and not more than 135.0percent of the labeled amount of gentamicin.
Packaging and storage— Preserve in collapsible tubes or in other tight containers,and avoid exposure to excessive heat.
Identification— Shake a quantity of Cream,equivalent to about 5mg of gentamicin,with a mixture of 200mLof chloroform and 5mLof water.Allow to separate,and filter the aqueous phase:the filtrate so obtained meets the requirements of the Identificationtest under Gentamicin Injection.
Minimum fill á755ñ: meets the requirements.
Assay— Proceed with Cream as directed in the Assayunder Gentamicin Sulfate Ointment.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 896
Phone Number:1-301-816-8335