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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 90.0percent and not more than 125.0percent 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 Iglass.
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 Identificationtest under Gentamicin Injection,Uterine Infusion being used instead of Injection.
Sterility á71ñ—
It meets the requirements when tested as directed for Membrane Filtrationin Test for Sterility of the Product To Be Examined.
pHá791ñ:
between 3.0and 5.5.
Assay—
Proceed as directed for gentamicin under Antibiotics—Microbial Assays á81ñ,using an accurately measured volume of Uterine Infusion diluted quantitatively and stepwise with Buffer No.3to yield a Test Dilutionhaving a concentration assumed to be equal to the median dose level of the Standard (0.1µg of gentamicin per mL).
Auxiliary Information—
Staff Liaison:Ian DeVeau,Ph.D.,Senior Scientist
Expert Committee:(VET)Veterinary Drugs
USP28–NF23Page 896
Phone Number:1-301-816-8178
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