» Desoxycorticosterone Acetate contains not less than 97.0 percent and not more than 103.0 percent of C23H32O4, calculated on the dried basis.
Packaging and storage Preserve in well-closed, light-resistant containers. Store at 25, excursions permitted between 15 and 30.
B: Ultraviolet Absorption 197U
Solution: 10 µg per mL.
Absorptivities at 240 nm, calculated on the dried basis, do not differ by more than 3.0%.
Melting range 741: between 155 and 161.
Specific rotation 781S: between +171 and +179.
Test solution: 10 mg, undried, per mL, in dioxane.
Loss on drying 731 Dry it in vacuum over silica gel for 4 hours: it loses not more than 0.5% of its weight.
Standard preparation Prepare as directed for Standard Preparation under Assay for Steroids 351, using USP Desoxycorticosterone Acetate RS.
Assay preparation Accurately weigh about 100 mg of Desoxycorticosterone Acetate, dissolve in sufficient alcohol to make 200.0 mL, and mix. Pipet 5 mL of this solution into a 250-mL volumetric flask, add alcohol to volume, and mix. Pipet 20 mL of the resulting solution into a glass-stoppered, 50-mL conical flask.
Procedure Proceed as directed for Procedure under Assay for Steroids 351. Calculate the quantity, in mg, of C23H32O4 in the Desoxycorticosterone Acetate taken by the formula:
10C(AU / AS).
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USP32NF27 Page 2081Pharmacopeial Forum: Volume No. 29(5) Page 1456