Fluocinolone Acetonide Reference Standard (Control 981) of National Institute of Health Sciences
Iwata, M.; Maekawa, K.; Saito, H.; Tanimoto, T.; Okada, S.
Kokuritsu Iyakuhin Shokuhin Eisei Kenkyujo Hokoku 1999(117): 202-204
1999
ISSN/ISBN: 1343-4292 PMID: 10939860 Document Number: 508025
The raw material of fluocinolone acetonide was examined for preparation of the "Fluocinolone Acetonide Reference Standard (Control 981)". The analytical data obtained were: melting point, 271.5 degree C; UV spectrum, Lambda max of 237.0 nm and specific absorbance in ethanol at 237 nm of 359.3; IR spectrum, same as that of the Fluocinolone Acetonide Reference Standard (Control 904); optical rotation, ɑ20(D) = + 102.8; thin-layer chromatography, no impurities detected; high-performance liquid chromatography, one impurity detected and total amount estimated to be about 0.17%; loss on drying, 0.29%; assay by HPLC, 100.9%. Based on the above results, the raw material was authorized as the Fluocinolone Acetonide Reference Standard (Control 981) of the National Institute of Health Sciences.