[The Cyclandelate Reference Standard (Control 931) of the National Institute of Health Sciences].

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

Raw cyclandelate material was tested for preparation of the "Cyclandelate Reference Standard (Control 931)". Analytical data obtained were as follows: melting point, 57.4 degrees C; ultraviolet spectrum, lambdamax = 252.0, 258.1 and 264.1 nm and E 1cm 1% = 5.85 (252.0 nm), 6.95 (258.1 nm), 5.30 (264.1 nm), respectively; infrared spectrum, the same as that of the JP Cyclandelate Reference Standard; thin-layer chromatography, no impurities were detected up to 1000 micro g; high-performance liquid chromatography (HPLC), no impurities were detected; loss on drying, 0.03%; assay result, 101.4% by HPLC. Based on the above findings, the raw material was authorized as the JP Cyclandelate Reference Standard (Control 931).

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[国家卫生科学研究所的环环素参考标准(控制931)]。
为制备“环青酸参比标准品(对照品931)”,对环青酸原料进行了测试。得到的分析数据如下:熔点57.4℃;紫外光谱,lambdamax = 252.0、258.1、264.1 nm, e1cm 1%分别= 5.85 (252.0 nm)、6.95 (258.1 nm)、5.30 (264.1 nm);红外光谱,与JP Cyclandelate参考标准相同;薄层色谱法,达1000微g未检出杂质;高效液相色谱法,未检出杂质;干燥损失0.03%;HPLC法测定结果为101.4%。基于上述发现,该原料被授权为JP Cyclandelate参考标准(Control 931)。
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