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[Epinephrine Bitartrate Reference Standard (Control 951) of National Institute of Health Sciences]

A Kitajima, Y Tagashira, K Maekawa, K Yoshii, H Komatsu, T Tanimoto, S Okada

Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 1997;(115):181-3.

PMID: 9641838

Abstract:

The raw material for epinephrine bitartrate was tested for preparation of the "Epinephrine Bitartrate Reference Standard (Control 951)" of National Institute of Health Sciences. Analytical data obtained were as follows: melting point, 148.6 degrees C (decomposition); UV spectrum, lambda max = 279 nm; IR spectrum, the same as that of JP Epinephrine Bitartrate Reference Standard (Control 792); optical rotation, [alpha]20D = -52.8 degrees; thin-layer chromatography, one impurity was detected; high-performance liquid chromatography, no impurity was detected; loss on drying, 0.01%; assay, 99.6% by potentiometric titration, 100.3% by spectrophotometry. Based on the above results, the raw material was authorized as the Epinephrine Bitartrate Reference Standard (Control 951) of National Institute of Health Sciences (Japanese Pharmacopoeia).

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