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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.
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— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Daniel K. Bempong, Ph.D.
Senior Scientist
(MDPS05) Monograph Development-Pulmonary and Steroids
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 3684
Pharmacopeial Forum: Volume No. 29(5) Page 1585
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.