U.S. PHARMACOPEIA

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Gentamicin Uterine Infusion
» 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.
Packaging and storage— Preserve in single-dose or multiple-dose containers, preferably of Type I glass.
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.
Identification— It responds to the Identification test under Gentamicin Injection, Uterine Infusion being used instead of Injection.
Sterility 71— It meets the requirements when tested as directed for Membrane Filtration in Test for Sterility of the Product To Be Examined.
pH 791: between 3.0 and 5.5.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
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 No. 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).
Auxiliary Information— Staff Liaison : Ian DeVeau, Ph.D., Associate Director
Expert Committee : (VET05) Veterinary Drugs 05
USP29–NF24 Page 994
Phone Number : 1-301-816-8178