U.S. PHARMACOPEIA

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Desoxycorticosterone Pivalate Injectable Suspension
» Desoxycorticosterone Pivalate Injectable Suspension is a sterile suspension of Desoxycorticosterone Pivalate in an aqueous medium. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C26H38O4.
Packaging and storage— Preserve in single-dose or multiple-dose containers, preferably of Type I glass, protected from light.
Labeling— Label Suspension to indicate that it is for veterinary use only.
Identification— Centrifuge a portion of Suspension, decant the supernatant, wash the residue by stirring with several successive portions of water, centrifuging and decanting each time, and finally dry the residue at 105: the desoxycorticosterone pivalate so obtained melts between 198 and 204, and when about 5 mg of the residue is dissolved in 2 mL of sulfuric acid, the solution is yellowish, with a greenish fluorescence. Dilute the solution with 2 mL of water: the color changes to a dark red-blue, and on further dilution with 2 mL of water it is discharged.
Bacterial endotoxins 85— It contains not more than 2.78 USP Endotoxin Units per mg of desoxycorticosterone pivalate.
pH 791: between 5.0 and 7.0.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements under Injections 1.
Assay—
Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Desoxycorticosterone Pivalate.
Assay preparation— Using a “to contain” pipet, transfer an accurately measured volume of Suspension, equivalent to about 125 mg of desoxycorticosterone pivalate, to a 250-mL volumetric flask. Add about 200 mL of methanol, and sonicate to dissolve. Add 25.0 mL of the Internal standard solution, dilute with methanol to volume, and mix. Centrifuge a 20-mL portion at high speed for about 5 minutes. Filter the supernatant through a 5-µm disk, discarding the first 5 mL of the filtrate.
Procedure— Proceed as directed for Procedure in the Assay under Desoxycorticosterone Pivalate. Calculate the quantity, in mg, of C26H38O4 in each mL of the Suspension taken by the formula:
250(C / V)(RU / RS),
in which V is the volume, in mL, of Suspension taken, and the other terms are as previously defined.
Auxiliary Information— Staff Liaison : Ian DeVeau, Ph.D., Associate Director
Expert Committee : (VET05) Veterinary Drugs 05
USP29–NF24 Page 642
Phone Number : 1-301-816-8178