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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]

    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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