Testosterone
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
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Testosterone contains not less than 97.0 percent and not more than 103.0 percent of C19H28O2, calculated on the dried basis.
1 Packaging and storage
Preserve in well-closed containers. Store at 25°, excursions permitted between 15° and 30°.
USP Reference standards 〈11〉—
USP Testosterone RS
2 Identification
Change to read:
A: Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K (CN 1-May-2020) .
Change to read:
B: Spectroscopic Identification Tests 〈197〉, Ultraviolet-Visible Spectroscopy: 197U (CN 1-May-2020) —
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.
3 Assay
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 suficient 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.
