Testosterone Click to View Image C19H28O2 288.42
Androst-4-en-3-one,17-hydroxy-,(17b)-.
17b-Hydroxyandrost-4-en-3-one [58-22-0]. »Testosterone contains not less than 97.0percent and not more than 103.0percent of C19H28O2,calculated on the dried basis. Packaging and storage— Preserve in well-closed containers.Store at 25,excursions permitted between 15and 30. USP Reference standards á11ñ USP Testosterone RS. Identification— A:Infrared Absorption á197Kñ. B: Ultraviolet Absorption á197UñSolution: 10µg per mL. Medium: methanol. Melting range á741ñ: between 153and 157. Specific rotation á781Sñ: between +101and +105. Test solution: 10mg per mL,in dioxane. Loss on drying á731ñ Dry it in vacuum over phosphorus pentoxide for 4hours:it loses not more than 1.0%of its weight. Organic volatile impurities,Method Vá467ñ: meets the requirements. Solvent— Use dimethyl sulfoxide. Assay— Standard preparation— Prepare as directed under Single-Steroid Assay á511ñ,using USP Testosterone RS. Assay preparation— Accurately weigh about 20mg of Testosterone,previously dried;dissolve in a sufficient quantity of a mixture of equal volumes of alcohol and chloroform to make 10.0mL;and mix. Procedure— Proceed as directed for Procedureunder Single-Steroid Assay á511ñ,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 5minutes,and determine the absorbances of the supernatant in 1-cm cells at the wavelength of maximum absorbance at about 241nm,with a suitable spectrophotometer,against the blank.Calculate the quantity,in mg,of C19H28O2in the portion of Testosterone taken by the formula: 10C(AU/AS), in which Cis the concentration,in mg per mL,of USP Testosterone RSin the Standard preparation;and AUand ASare the absorbances of the solutions from the Assay preparationand the Standard preparation,respectively. Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist Expert Committee:(PA1)Pharmaceutical Analysis 1 USP28–NF23Page 1875 Pharmacopeial Forum:Volume No.29(5)Page 1585 Phone Number:1-301-816-8139