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 97.0 percent and not more than 103.0 percent of C23H32O4.
Packaging and storage— Preserve in tight containers suitable for maintaining sterile contents, holding one pellet each.
USP Reference standards 11
USP Desoxycorticosterone Acetate RS Click to View Structure
Solubility in alcohol— A solution of 25 mg of powdered Pellets in 1 mL of alcohol is clear and practically free from insoluble residue.
B: Ultraviolet Absorption 197U
Solution: 10 µg per mL.
Medium: alcohol.
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.
Sterility 71: meet the requirements.
Weight variation— Weigh 5 Pellets 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.
Standard preparation— Prepare as directed under Assay for Steroids 351, using USP Desoxycorticosterone Acetate RS.
Assay preparation— Weigh and finely powder not fewer than 10 Pellets. Weigh accurately about 100 mg of the powder, dissolve it in sufficient alcohol to make 200.0 mL, and mix. Transfer 5.0 mL of this solution to a 250-mL volumetric flask, dilute with alcohol to volume, and mix. Transfer 20.0 mL of this solution to 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 portion of Pellets taken by the formula:
10C(AU / AS).
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Domenick Vicchio, Ph.D.
Senior Scientific Liaison
(SM42010) Monographs - Small Molecules 4
Reference Standards RS Technical Services
71 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
(GCM2010) General Chapters - Microbiology
USP35–NF30 Page 2834