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.
USP Reference standards 11
USP Endotoxin RS
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.
Other requirements It meets the requirements under Injections 1.
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.
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USP35NF30 Page 2835