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The Dexamethasone Reference Standard (Control 931) of the National Institute of Health Sciences

Kitajima, A.; Yoshii, K.; Komatsu, H.; Ishimitsu, S.; Okada, S.

Eisei Shikenjo hokoku. Bulletin of National Institute of Hygienic Sciences 1994(112): 167-169

1994

ISSN/ISBN: 0077-4715
PMID: 8854922
Document Number: 423381
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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