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Estradiol Reference Standard (Control 001) of National Institute of Health Sciences

Iwata, M.; Koide, T.; Maekawa, K.; Saito, H.; Tanimoto, T.; Okada, S.

Kokuritsu Iyakuhin Shokuhin Eisei Kenkyujo Hokoku 2000(118): 151-153

2000

ISSN/ISBN: 1343-4292
PMID: 11534119
Document Number: 515625
The raw material of tocopherol was tested for the preparation of "Estradiol Reference Standard (Control 991)". Analytical data obtained were: melting point, 178.5 degrees C: UV spectrum, lambda max of 281 nm and specific absorbance in ethanol at lambda max = 77.7; IR spectrum, same as that of the Estradiol Reference Standard (Control 964); optical rotation, ɑD20 = +79.5 degrees; thin-layer chromatography, one impurity was detected; high-performance liquid chromatography (HPLC), total amount of impurities estimated to be less than 0.6%; loss on drying, 3.3%; assay, 100.2% by UV spectrophotometry and 99.9% by HPLC. Based on the above results, the raw material was authorized as the Estradiol Reference Standard (Control 001) of the National Institute of Health Sciences.

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