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, 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.

Residual solvents 467: meets the requirements.

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 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.

Expert Committee : (VET05) Veterinary Drugs 05

USP29–NF24 Page 1566

Phone Number : 1-301-816-8178