Desoxycorticosterone Acetate Injection
»Desoxycorticosterone Acetate Injection is a sterile solution of Desoxycorticosterone Acetate in vegetable oil.It contains not less than 90.0percent and not more than 115.0percent of the labeled amount of C23H32O4.
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Ior Type IIIglass,protected from light.
Identification— Evaporate 25mLof the Assay preparationfrom the Assayon a steam bath just to dryness,and dissolve the residue in 1mLof chloroform.Using this as the test solution,proceed as directed under Thin-Layer Chromatographic Identification Test á201ñ.
Bacterial endotoxins á85ñ— It contains not more than 71.4USP Endotoxin Units per mg of desoxycorticosterone acetate.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Alcohol-isooctaneand Isooctane-alcohol— Shake equal volumes of 90percent alcohol and isooctane in a separator for 10to 15minutes,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 Preparationunder Assay for Steroids á351ñ,using USP Desoxycorticosterone Acetate RS.
Assay preparation— Transfer an accurately measured volume of Injection,equivalent to about 5mg of desoxycorticosterone acetate,to a separator containing 50mLof Isooctane-alcohol.Extract with six 20-mLportions of Alcohol-isooctane,receiving the extracts in a 250-mLvolumetric flask,dilute with Alcohol-isooctaneto volume,and mix.Pipet 10mLof this solution into a glass-stoppered,50-mLconical flask,evaporate on a steam bath with the aid of a gentle current of air just to dryness,and dissolve the residue in 20.0mLof alcohol.
Procedure— Proceed as directed for Procedureunder Assay for Steroids á351ñ.Calculate the quantity,in mg,of C23H32O4in each mLof the Injection taken by the formula:
0.5(C/V)(AU/AS),
in which Vis the volume,in mL,of Injection taken.
Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 585
Phone Number:1-301-816-8139