Isoflupredone Acetate Injectable Suspension
» Isoflupredone Acetate Injectable Suspension contains not less than 90.0 percent and not more than 115.0 percent of the labeled amount of isoflupredone acetate (C23H29FO6).
Packaging and storage Preserve in single-dose or multiple-dose containers, preferably of Type I glass.
Labeling Label it to indicate that it is intended for veterinary use only.
USP Reference standards 11
USP Endotoxin RS
USP Prednisolone Acetate RS
Identification, Infrared Absorption 197M.
Test specimen Transfer about 25 mg of Injectable Suspension to a centrifuge tube, add 20 mL of water, and shake well. Centrifuge, and discard the liquid layer. Repeat this washing step with three additional 20-mL portions of water. Dry the material so obtained at 105 for 3 hours.
Bacterial endotoxins 85 It contains not more than 125 USP Endotoxin Units per mg of isoflupredone acetate.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791: between 5.0 and 7.5.
Other requirements It meets the requirements under Injections 1.
Mobile phase, Diluent, Internal standard solution, Standard preparation, and Chromatographic system Proceed as directed in the Assay under Isoflupredone Acetate.
Assay preparation Transfer an accurately measured volume of Injectable Suspension, equivalent to about 4 mg of isoflupredone acetate, to a suitable container. Add 8.0 mL of Internal standard solution and 32.0 mL of Diluent, and swirl to dissolve.
Procedure Proceed as directed for Procedure in the Assay under Isoflupredone Acetate. Calculate the quantity, in mg, of isoflupredone acetate (C23H29FO6) in each mL of Injectable Suspension taken by the formula:
(WS / V)(RU / RS)in which V is the volume, in mL, of Injectable Suspension taken to prepare the Assay preparation; and the other terms are as defined therein.
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USP35NF30 Page 3569Pharmacopeial Forum: Volume No. 27(4) Page 2751