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

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

Kokuritsu Iyakuhin Shokuhin Eisei Kenkyujo Hokoku 2001(119): 104-106

2001

ISSN/ISBN: 1343-4292
PMID: 11915279
Document Number: 531116
The raw material of Alprostadil was examined for the preparation of "Alprostadil Reference Standard (Control 001)". Analytical data obtained were: IR spectrum, same as that of the Alprostadil Reference Standard (Control 923); thin-layer chromatography, no impurities were detected until 20 micrograms; high-performance liquid chromatography (HPLC), total amount of impurities estimated to be less than 0.2%. Based on the above results, the raw material was authorized as the Japanese Pharmacopoeia Alprostadil Reference Standard (Control 001).

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