Cloxacillin Sodium Intramammary Infusion
» Cloxacillin Sodium Intramammary Infusion is a suspension of Cloxacillin Sodium in a suitable natural or chemically modified vegetable oil vehicle with a suitable dispersing agent. It has a potency equivalent to not less than 90.0 percent and not more than 120.0 percent of the labeled amount of cloxacillin (C19H18ClN3O5S).
Packaging and storage Preserve in disposable syringes that are well-closed containers, except that where the Intramammary Infusion is labeled as sterile, the individual syringes or cartons are sealed and tamper-proof so that sterility is assured at time of use.
USP Reference standards 11
Labeling Label it to indicate that it is for veterinary use only. Intramammary Infusion that is sterile may be so labeled.
Identification, Infrared Absorption 197K Obtain the test specimen as follows. Transfer a quantity of Intramammary Infusion, equivalent to about 500 mg of cloxacillin, to a 50-mL centrifuge tube, add 15 mL of isooctane, mix, and centrifuge. Decant and discard the isooctane. Wash the residue with two 15-mL portions of isooctane and two 15-mL portions of ethyl ether, and discard the washings. Dry the residue in a current of air.
Sterility 71 (where labeled as being sterile) It meets the requirements when tested as directed for Direct Inoculation of the Culture Medium under Test for Sterility of the Product to be Examined, except to use Fluid Thioglycollate Medium containing polysorbate 80 solution (1 in 200) and an amount of sterile penicillinase sufficient to inactivate the cloxacillin in each tube, to use SoybeanCasein Digest Medium containing polysorbate 80 solution (1 in 200) and an amount of sterile penicillinase sufficient to inactivate the cloxacillin in each tube, and to shake the tubes once daily.
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 cloxacillin under AntibioticsMicrobial Assays 81, expelling the contents of 1 syringe of Intramammary Infusion into a high-speed glass blender jar containing 499.0 mL of Buffer No. 1 and 1.0 mL of polysorbate 80, and blending for 3 to 5 minutes. Allow to stand for 10 minutes, and dilute an accurately measured volume of the aqueous phase quantitatively and stepwise with Buffer No. 1 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
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USP35NF30 Page 2748