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

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.