Isoflupredone Acetate Injectable Suspension

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

DOWNLOAD PDF HERE

Isoupredone Acetate Injectable Suspension contains not less than 90.0 percent and not more than 115.0 percent of the labeled amount of isoupredone 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 Isoupredone Acetate RS 

USP Prednisolone Acetate RS 

Change to read: 

Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy:197M (CN 1-May-2020) . 

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 Test 〈85〉 —It contains not more than 125 USP Endotoxin Units per mg of isoupredone acetate. Sterility Tests 〈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 and Implanted Drug Products 〈1〉. 

Assay— 

Mobile phase, Diluent, Internal standard solution, Standard preparation, and Chromatographic system—Proceed as directed in the Assay under Isoupredone Acetate. 

Assay preparation—Transfer an accurately measured volume of Injectable Suspension, equivalent to about 4 mg of isoupredone 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 Isoupredone Acetate. Calculate the quantity, in mg, of isoupredone acetate (C₂₃H₂₉FO₆) in each mL of Injectable Suspension taken by the formula: 

(W_S/V)(R_U/R_S) 

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.