Gentamicin Sulfate Ointment
If you find any inaccurate information, please let us know by providing your feedback here
Tóm tắt nội dung
This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
Gentamicin Sulfate Ointment contains the equivalent of not less than 90.0 percent and not more than 135.0 percent of the labeled amount of gentamicin.
1 Packaging and storage
Preserve in collapsible tubes or other tight containers, and avoid exposure to excessive heat.
USP Reference standards 〈11〉
USP Gentamicin Sulfate RS
2 Identification
Shake a quantity of Ointment, 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 layer: the filtrate so obtained meets the requirements of the Identification test under Gentamicin Injection.
Minimum fill 〈755〉: meets the requirements.
Water Determination, Method I 〈921〉: not more than 1.0%, 20 mL of a mixture of toluene and methanol (7:3) being used in place of methanol in the titration vessel.
3 Assay
Proceed with Ointment as directed under Antibiotics—Microbial Assays 〈81〉, using an accurately weighed quantity of Ointment, equivalent to about 1 mg of gentamicin, shaken with about 50 mL of ether in a separator, and extracted with four 20-mL portions of Buffer B.3. Combine the aqueous extracts, and dilute quantitatively and stepwise with Buffer B.3 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
