Desoxycorticosterone Acetate Pellets
»Desoxycorticosterone Acetate Pellets are sterile pellets composed of Desoxycorticosterone Acetate in compressed form,without the presence of any binder,diluent,or excipient.They contain not less than 97.0percent and not more than 103.0percent of C23H32O4.
Packaging and storage—
Preserve in tight containers suitable for maintaining sterile contents,holding one pellet each.
Solubility in alcohol—
Asolution of 25mg of powdered Pellets in 1mLof alcohol is clear and practically free from insoluble residue.
Identification—
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%.
Specific rotation á781Sñ:
between +171
and +179.
and +179.
Test solution:
10mg,undried,per mL,in dioxane.
Sterility á71ñ:
meet the requirements.
Weight variation—
Weigh 5Pellets singly,and calculate the average weight.The average weight is not less than 95%and not more than 105%of the labeled weight of C23H32O4,and each Pellet weighs not less than 90%and not more than 110%of the labeled weight of C23H32O4.
Assay—
Standard preparation—
Prepare as directed under Assay for Steroids á351ñ,using USP Desoxycorticosterone Acetate RS.
Assay preparation—
Weigh and finely powder not fewer than 10Pellets.Weigh accurately about 100mg of the powder,dissolve it in sufficient alcohol to make 200.0mL,and mix.Transfer 5.0mLof this solution to a 250-mLvolumetric flask,dilute with alcohol to volume,and mix.Transfer 20.0mLof this solution to a glass-stoppered,50-mLconical flask.
Procedure—
Proceed as directed for Procedureunder Assay for Steroids á351ñ.Calculate the quantity,in mg,of C23H32O4in the portion of Pellets 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 586
Phone Number:1-301-816-8139