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 Isoflupredone Acetate 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.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ian DeVeau, Ph.D.
Director, Veterinary Drugs and Radiopharmaceuticals
(VET05) Veterinary Drugs 05
Reference Standards Lili Wang, Technical Services Scientist
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 2695
Pharmacopeial Forum: Volume No. 27(4) Page 2751
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.