[国家卫生科学研究所丙酸睾酮参考标准(对照品881)]。

S Ishimitsu, A Kitajima, K Yoshii, H Komatsu, S Okada
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引用次数: 0

摘要

为制备“丙酸睾酮对照品(对照品881)”,对丙酸睾酮原料进行了检测。得到的分析数据如下:干燥损失0.1%;熔点:120.6℃;旋光度[α]20D = + 85.4度;紫外光谱,λ达max = 241 nm,比吸光度e1cm1% (241 nm) = 483;红外光谱,与美国国立卫生研究院丙酸睾酮标准品相同;薄层色谱法,未检出杂质;高效液相色谱法,检出1个杂质;紫外分光光度法测定结果为100.6%。基于上述发现,该原料被批准为国家卫生科学研究所丙酸睾酮参考标准品(Control 881)。
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[The Testosterone Propionate Reference Standard (Control 881) of the National Institute of Health Sciences].

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.

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