Novobiocin Sodium Intramammary 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)
Novobiocin Sodium Intramammary Infusion is a suspension of Novobiocin Sodium in a suitable vegetable oil vehicle. It contains suitable preservative and suspending agents. It contains the equivalent of not less than 90.0 percent and not more than 125.0 percent of the labeled amount of novobiocin (C31H36N2O11).
Packaging and storage-Preserve in disposable syringes that are well-closed containers.
Labeling-Label it to indicate that it is for veterinary use only.
USP REFERENCE STANDARDS (11)
USP Novobiocin RS
WATER DETERMINATION, Method | (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.
Assay-Proceed as directed for novobiocin under Antibiotics-Microbial Assays (81), expelling the contents of a syringe of Intramammary Infusion into a high-speed blender jar containing 1.0 mL of Polysorbate 80 and 499.0 mL of Buffer B.3, and blend for 3 to 5 minutes. Allow to stand for 10 minutes, and dilute quantitatively and stepwise with Buffer B.6 to obtain a Test Dilution having a concentration of novobiocin assumed to be equal to the median dose level of the Standard.
