[The Alprostajil Reference Standard (Control 921) of the National Institute of Health Sciences].

A Kitajima, K Yoshii, H Komatsu, S Ishimitsu, S Okada
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Abstract

Raw alprostajil material was examined for preparation of the "Alprostajil Reference Standard (Control 921)". Analytical data obtained were as follows: infrared spectrum, the same as that of the USP Alprostajil Reference Standard; thin-layer chromatography, no impurities were detected up to 20 micro g; high-performance liquid chromatography (HPLC), no impurities were detected; assay result, 99.6% by HPLC. Based on the above findings, this raw material was authorized as the NIHS Alprostajil Reference Standard (Control 921).

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[国家卫生科学研究所阿普斯塔伊参比标准(Control 921)]。
为制备“阿前列吉尔标准品(对照品921)”,对阿前列吉尔原料进行检验。获得的分析数据如下:红外光谱与USP阿普斯塔伊参比标准品相同;薄层色谱法,20 μ g以内未检出杂质;高效液相色谱法,未检出杂质;高效液相色谱法测定结果为99.6%。基于上述发现,该原料被批准为美国国家卫生研究院(NIHS)阿普斯塔吉参考标准品(Control 921)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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