Gentamicin Sulfate Cream
» Gentamicin Sulfate Cream contains the equivalent of not less than 90.0 percent and not more than 135.0 percent of the labeled amount of gentamicin.
Packaging and storage— Preserve in collapsible tubes or in other tight containers, and avoid exposure to excessive heat.
USP Reference standards 11
USP Gentamicin Sulfate RS Click to View Structure
Identification— Shake a quantity of Cream, equivalent to about 5 mg of gentamicin, with a mixture of 200 mL of chloroform and 5 mL of water. Allow to separate, and filter the aqueous phase: the filtrate so obtained meets the requirements of the Identification test under Gentamicin Injection.
Minimum fill 755: meets the requirements.
Assay— Proceed with Cream as directed in the Assay under Gentamicin Sulfate Ointment.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
Senior Scientific Liaison
(SM12010) Monographs - Small Molecules 1
Reference Standards RS Technical Services
USP35–NF30 Page 3326