[The Testosterone Propionate Reference Standard (Control 881) of the National Institute of Health Sciences].

Abstract

Raw testosterone propionate material was tested for preparation of the "Testosterone Propionate Reference Standard (Control 881)". Analytical data obtained were as follows: loss on drying, 0.1%; melting point, 120.6 degrees C; optical rotation [alpha]20D = + 85.4 degrees; ultraviolet spectrum, lambdamax = 241 nm and specific absorbance E 1cm1% (241 nm) = 483; infrared spectrum, the same as that of the NIHS Testosterone Propionate Reference Standard; thin-layer chromatography, no impurities were detected; high-performance liquid chromatography (HPLC), one impurity was detected; assay result, 100.6% by UV spectrophotometry. Based on the above findings, the raw material was authorized as the Testosterone Propionate Reference Standard (Control 881) of the National Institute of Health Sciences.