Novobiocin Sodium Intramammary Infusion
» 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.
Water, 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.
Assay Proceed as directed for novobiocin under AntibioticsMicrobial 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 No. 3, and blend for 3 to 5 minutes. Allow to stand for 10 minutes, and dilute quantitatively and stepwise with Buffer No. 6 to obtain a Test Dilution having a concentration of novobiocin assumed to be equal to the median dose level of the Standard.
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USP32NF27 Page 3121