Desoxycorticosterone Acetate, chemical structure, molecular formula, Reference Standards

Desoxycorticosterone Acetate

C23H32O4 372.50

Pregn-4-ene-3,20-dione,21-(acetyloxy)-.
11-Deoxycorticosterone acetate [56-47-3].

»Desoxycorticosterone Acetate contains not less than 97.0percent and not more than 103.0percent 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

USP Reference standards á11ñ— USP Desoxycorticosterone Acetate RS.

Identification—

A:Infrared Absorption á197Kñ.

B:Ultraviolet Absorption á197Uñ—

Solution: 10µg per mL.

Medium: alcohol.

Absorptivities at 240nm,calculated on the dried basis,do not differ by more than 3.0%.

Melting range á741ñ: between 155

and 161

Specific rotation á781Sñ: between +171

and +179

Test solution: 10mg,undried,per mL,in dioxane.

Loss on drying á731ñ— Dry it in vacuum over silica gel for 4hours:it loses not more than 0.5%of its weight.

Assay—

Standard preparation— Prepare as directed for Standard Preparationunder Assay for Steroids á351ñ,using USP Desoxycorticosterone Acetate RS.

Assay preparation— Accurately weigh about 100mg of Desoxycorticosterone Acetate,dissolve in sufficient alcohol to make 200.0mL,and mix.Pipet 5mLof this solution into a 250-mLvolumetric flask,add alcohol to volume,and mix.Pipet 20mLof the resulting solution into a glass-stoppered,50-mLconical flask.

Procedure— Proceed as directed for Procedureunder Assay for Steroids á351ñ.Calculate the quantity,in mg,of C23H32O4in the Desoxycorticosterone Acetate taken by the formula:

10C(AU/AS).

Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist

Expert Committee:(PA1)Pharmaceutical Analysis 1

USP28–NF23Page 585

Pharmacopeial Forum:Volume No.29(5)Page 1456

Phone Number:1-301-816-8139