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C19H28O2 288.42

Androst-4-en-3-one, 17-hydroxy-, (17)-.
17-Hydroxyandrost-4-en-3-one [58-22-0].
» Testosterone contains not less than 97.0 percent and not more than 103.0 percent of C19H28O2, calculated on the dried basis.
Packaging and storage— Preserve in well-closed containers. Store at 25, excursions permitted between 15 and 30.
B: Ultraviolet Absorption 197U
Solution: 10 µg per mL.
Medium: methanol.
Melting range 741: between 153 and 157.
Specific rotation 781S: between +101 and +105.
Test solution: 10 mg per mL, in dioxane.
Loss on drying 731 Dry it in vacuum over phosphorus pentoxide for 4 hours: it loses not more than 1.0% of its weight.
Organic volatile impurities, Method V 467: meets the requirements.
Solvent— Use dimethyl sulfoxide.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Standard preparation— Prepare as directed under Single-Steroid Assay 511, using USP Testosterone RS.
Assay preparation— Accurately weigh about 20 mg of Testosterone, previously dried; dissolve in a sufficient quantity of a mixture of equal volumes of alcohol and chloroform to make 10.0 mL; and mix.
Procedure— Proceed as directed for Procedure under Single-Steroid Assay 511, using a solvent system consisting of a mixture of benzene and ethyl acetate (1:1), through the fourth sentence of the second paragraph under Procedure. Then centrifuge the tubes for 5 minutes, and determine the absorbances of the supernatant in 1-cm cells at the wavelength of maximum absorbance at about 241 nm, with a suitable spectrophotometer, against the blank. Calculate the quantity, in mg, of C19H28O2 in the portion of Testosterone taken by the formula:
10C(AU / AS),
in which C is the concentration, in mg per mL, of USP Testosterone RS in the Standard preparation; and AU and AS are the absorbances of the solutions from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Staff Liaison : Daniel K. Bempong, Ph.D., Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP29–NF24 Page 2087
Pharmacopeial Forum : Volume No. 29(5) Page 1585
Phone Number : 1-301-816-8143