Isoflupredone Acetate Injectable Suspension
»Isoflupredone Acetate Injectable Suspension contains not less than 90.0percent and not more than 115.0percent of the labeled amount of isoflupredone acetate (C23H29FO6).
Packaging and storage— Preserve in single-dose or multiple-dose containers,preferably of Type Iglass.
Labeling— Label it to indicate that it is intended for veterinary use only.
Identification,Infrared Absorption á197Mñ.
Test specimen— Transfer about 25mg of Injectable Suspension to a centrifuge tube,add 20mLof water,and shake well.Centrifuge,and discard the liquid layer.Repeat this washing step with three additional 20-mLportions of water.Dry the material so obtained at 105for 3hours.
Bacterial endotoxins á85ñ— It contains not more than 125USP Endotoxin Units per mg of isoflupredone acetate.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
pHá791ñ: between 5.0and 7.5.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Mobile phase,Diluent,Internal standard solution,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Isoflupredone Acetate.
Assay preparation— Transfer an accurately measured volume of Injectable Suspension,equivalent to about 4mg of isoflupredone acetate,to a suitable container.Add 8.0mLof Internal standard solutionand 32.0mLof Diluent,and swirl to dissolve.
Procedure— Proceed as directed for Procedurein the Assayunder Isoflupredone Acetate.Calculate the quantity,in mg,of isoflupredone acetate (C23H29FO6)in each mLof Injectable Suspension taken by the formula:
(WS/V)(RU/RS),
in which Vis the volume,in mL,of Injectable Suspension taken to prepare the Assay preparation;and the other terms are as defined therein.
Auxiliary Information— Staff Liaison:Ian DeVeau,Ph.D.,Senior Scientist
Expert Committee:(VET)Veterinary Drugs
USP28–NF23Page 1069
Pharmacopeial Forum:Volume No.27(4)Page 2751
Phone Number:1-301-816-8178