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[国立卫生科学研究所的倍他米松磷酸钠对照品(对照品881)]

[Betamethasone Sodium Phosphate Reference Standard (Control 881) of National Institute of Hygienic Sciences].

作者信息

Okada S, Hiroshige R, Tanaka M, Murai M, Kimura T

出版信息

Eisei Shikenjo Hokoku. 1990(108):141-4.

PMID:1364345
Abstract

The raw material of betamethasone sodium phosphate was examined for preparation of the "Betamethasone Sodium Phosphate Reference Standard". Analytical results for the sample were as follows: pH 7.90; optical rotation + 100.5 degrees; IR spectrum the same as USP Reference Standard of Betamethasone Sodium Phosphate; TLC indicated no impurities, but 5 kinds of impurities were detected in small amounts by HPLC; water content 14.7%; assay 100.2% by HPLC. Based on the above results, this raw material was authorized to be the Reference Standard of the National Institute of Hygienic Sciences.

摘要

对倍他米松磷酸钠原料药进行检测,以制备“倍他米松磷酸钠对照品”。该样品的分析结果如下:pH值7.90;旋光度+100.5度;红外光谱与美国药典倍他米松磷酸钠对照品相同;薄层色谱法表明无杂质,但高效液相色谱法检测到有5种少量杂质;含水量14.7%;高效液相色谱法测定含量为100.2%。基于上述结果,该原料药被批准为国家卫生科学研究所对照品。

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