Gentamicin Uterine Infusion
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
Gentamicin Uterine Infusion is a sterile solution of Gentamicin Sulfate in Water for Injection. It contains not less than 90.0 percent and not more than 125.0 percent of the labeled amount of gentamicin. It may contain suitable buffers, preservatives, and sequestering agents.
1 Packaging and storage
Preserve in single-dose or multiple-dose containers, preferably of Type I glass.
2 Labeling
Label Uterine Infusion to indicate that it is for veterinary use only. The label states that it must be diluted with 0.9% Sodium Chloride Irrigation before aseptic uterine infusion.
USP Reference standards 〈11〉
USP Gentamicin Sulfate RS
3 Identification
It responds to the Identification test under Gentamicin Injection, Uterine Infusion being used instead of Injection.
Sterility Tests 〈71〉 - It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 〈791〉: between 3.0 and 5.5.
4 Assay
Proceed as directed for gentamicin under Antibiotics—Microbial Assays 〈81〉, using an accurately measured volume of Uterine Infusion diluted quantitatively and stepwise with Buffer B.3 to yield a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard (0.1 μg of gentamicin per mL).
