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.

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.

Residual solvents 467: meets the requirements.

Assay— Proceed with Cream as directed in the Assay under Gentamicin Sulfate Ointment.

Expert Committee : (MDANT05) Monograph Development-Antibiotics

USP29–NF24 Page 994

Phone Number : 1-301-816-8223