U.S. PHARMACOPEIA

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Desoxycorticosterone Acetate Injection
» Desoxycorticosterone Acetate Injection is a sterile solution of Desoxycorticosterone Acetate in vegetable oil. It contains not less than 90.0 percent and not more than 115.0 percent of the labeled amount of C23H32O4.
Packaging and storage— Preserve in single-dose or multiple-dose containers, preferably of Type I or Type III glass, protected from light.
Identification— Evaporate 25 mL of the Assay preparation from the Assay on a steam bath just to dryness, and dissolve the residue in 1 mL of chloroform. Using this as the test solution, proceed as directed under Thin-Layer Chromatographic Identification Test 201.
Bacterial endotoxins 85— It contains not more than 71.4 USP Endotoxin Units per mg of desoxycorticosterone acetate.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements under Injections 1.
Assay—
Alcohol-isooctane and Isooctane-alcohol— Shake equal volumes of 90 percent alcohol and isooctane in a separator for 10 to 15 minutes, and allow to separate. Withdraw the layers into separate containers, designating the lower layer as “alcohol-isooctane” and the upper layer as “isooctane-alcohol.”
Standard preparation— Prepare as directed for Standard Preparation under Assay for Steroids 351, using USP Desoxycorticosterone Acetate RS.
Assay preparation— Transfer an accurately measured volume of Injection, equivalent to about 5 mg of desoxycorticosterone acetate, to a separator containing 50 mL of Isooctane-alcohol. Extract with six 20-mL portions of Alcohol-isooctane, receiving the extracts in a 250-mL volumetric flask, dilute with Alcohol-isooctane to volume, and mix. Pipet 10 mL of this solution into a glass-stoppered, 50-mL conical flask, evaporate on a steam bath with the aid of a gentle current of air just to dryness, and dissolve the residue in 20.0 mL of alcohol.
Procedure— Proceed as directed for Procedure under Assay for Steroids 351. Calculate the quantity, in mg, of C23H32O4 in each mL of the Injection taken by the formula:
0.5(C / V)(AU / AS),
in which V is the volume, in mL, of Injection taken.
Auxiliary Information— Staff Liaison : Daniel K. Bempong, Ph.D., Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP29–NF24 Page 641
Phone Number : 1-301-816-8143