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

—
USP Desoxycorticosterone Acetate RS.

Solubility in alcohol— A solution of 25 mg of powdered Pellets in 1 mL of alcohol is clear and practically free from insoluble residue.

Identification—

A: Infrared Aborption

197K

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

: 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.

Assay—

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	Daniel K. Bempong, Ph.D. Senior Scientist 1-301-816-8143	(MDPS05) Monograph Development-Pulmonary and Steroids
Reference Standards	Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org
71	Radhakrishna S Tirumalai, Ph.D. Senior Scientist 1-301-816-8339	(MSA05) Microbiology and Sterility Assurance

USP32–NF27 Page 2082