[国家卫生科学研究所地塞米松参比标准(Control 931)]。

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

摘要

为制备地塞米松标准品(对照品931),对地塞米松原料进行了检测。得到的分析数据如下:熔点245.1℃(分解);红外光谱,与JP地塞米松标准品相同;旋光度,- α - 20d = + 76.75度;薄层色谱法,检出两种杂质;高效液相色谱法,检出1个杂质;干燥损失0.14%;高效液相色谱法测定结果为99.4%。基于上述发现,该原料被批准为JP地塞米松标准品(对照品931)。
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[The Dexamethasone Reference Standard (Control 931) of the National Institute of Health Sciences].

Raw dexamethasone material was tested for preparation of the "Dexamethasone Reference Standard (Control 931)". Analytical data obtained were as follows: melting point, 245.1 degrees C (decomposition); infrared spectrum, the same as that of the JP Dexamethasone Reference Standard; optical rotation, -alpha-20D = + 76.75 degrees; thin-layer chromatography, two impurities were detected; high-performance liquid chromatography (HPLC), one impurity was detected; loss on drying, 0.14%; assay result, 99.4% by HPLC. Based on the above findings, the raw material was authorized as the JP Dexamethasone Reference Standard (Control 931).

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