Amoxicillin Intramammary Infusion
» Amoxicillin Intramammary Infusion is a suspension of Amoxicillin in a suitable vegetable oil vehicle. It contains not less than 90.0 percent and not more than 120.0 percent of the labeled amount of amoxicillin (C16H19N3O5S). It contains a suitable dispersing agent and preservative.
Packaging and storage Preserve in well-closed disposable syringes.
Labeling Label it to indicate that it is intended for veterinary use only.
Identification Transfer a quantity of Intramammary Infusion, equivalent to about 60 mg of amoxicillin, 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. Add 15 mL of 0.1 N hydrochloric acid to the residue, and mix. The solution obtained responds to the Identification test under Amoxicillin Capsules.
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 amoxicillin under AntibioticsMicrobial Assays 81. Expel the contents of 1 syringe of Intramammary Infusion into a high-speed glass blender jar containing 499.0 mL of Buffer No. 3 and 1.0 mL of polysorbate 80, and blend for 3 to 5 minutes. Allow to stand for about 10 minutes, and dilute an accurately measured volume of the aqueous phase quantitatively and stepwise with Buffer No. 3 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
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USP32NF27 Page 1541