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.
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 25 mL of toluene, mix, and centrifuge. Decant and discard the toluene. Wash the residue with four 25-mL portions of toluene, sonicating for about 30 seconds after each addition of toluene. Dry the residue in vacuum over silica gel.
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 sufficient methanol to yield a volume of 500 mL, and blend for 3 to 5 minutes. Promptly dilute an accurately measured volume of this solution 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.
Auxiliary Information
Staff Liaison :
Ian DeVeau, Ph.D., Associate Director
Expert Committee : (VET05) Veterinary Drugs 05
USP29NF24 Page 572
Pharmacopeial Forum : Volume No. 31(4) Page 1051
Phone Number : 1-301-816-8178