Kitajima A, Yoshii K, Komatsu H, Ishimitsu S, Okada S
Eisei Shikenjo Hokoku. 1994(112):188-91.
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).
对前列腺素E1原料药进行检验，以制备“前列腺素E1对照品（对照921）”。所得分析数据如下：红外光谱，与美国药典前列腺素E1对照品相同；薄层色谱法，在20μg时未检测到杂质；高效液相色谱法（HPLC），未检测到杂质；含量测定结果，HPLC法测定为99.6%。基于上述结果，该原料药被批准为国立卫生研究院前列腺素E1对照品（对照921）。
