Testosterone
;)
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.
,excursions permitted between 15and 30.
Identification—
A:Infrared Absorption á197Kñ.
Specific rotation á781Sñ:
between +101and +105.
and +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