PMID: 11915296Mar 28, 2002Paper

Berberine Hydrochloride Reference Standard (Control 001) of National Institute of Health Sciences

Kokuritsu Iyakuhin Shokuhin Eisei Kenkyūjo hōkoku = Bulletin of National Institute of Health Sciences
Tatsuo KoideS Okada

Abstract

The raw material of Berberine Hydrochloride was examined for preparation of the "Berberine Hydrochloride Reference Standard". The analytical data obtained were: UV spectrum: lambda max, 420, 345, 263 and 228 nm and specific absorbance (E1ca1%) in ethanol at each lambda max, 155, 724, 796 and 820, respectively; IR spectrum, specific absorptions at 2844, 1635, 1569, and 1506 cm-1; and the spectrum of raw material was consistent with that of Standard (Control 941). Also, thin-layer chromatography, an impurity was detected; high-performance liquid chromatography, several impurities were detected. The amount of each impurity was estimated at less than 0.1% and the total amount of impurities was less than 0.2%. Based on the above results, the candidate material was authorized as the Berberine Hydrochloride Reference Standard (Control 001) of the National Institute of Health Sciences.

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