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    Eisei Shikenjo Hokoku. 1991;(109):148-50.

    [Diclofenamide Reference Standard (Control 891) of National Institute of Hygienic Sciences].

    [Article in Japanese]
    Okada S, Izumi W, Murai M, Komatsu H, Ishimitsu S.

    Abstract

    Quality of the raw material of diclofenamide was evaluated for preparation of "Diclofenamide Reference Standard". Analytical results for the sample were as follows: melting point 240 degrees C (decomposition); UV spectrum indicates absorption maxima at 286 and 295 nm and the absorption ratio A286/A295 1.04; IR spectrum is same as that of the USP Reference Standard; no impurity was found by TLC, but a trace of one was found by HPLC analysis; the purity is assumed to be 99.95% by HPLC analysis; loss on drying 0.1%; assay by HPLC against USP Reference Standard 100.2%. Based on the results, the present raw material was authorized to be the Reference Standard of the National Institute of Hygienic Sciences.

    PMID:
    1364383
    [PubMed - indexed for MEDLINE]

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