[Tolnaftate Reference Standard (Control 901) of National Institute of Hygienic Sciences].

The raw material of tolnaftate was examined for the preparation of the "Tolnaftate Reference Standard". Analytical data obtained were as follows: ultraviolet spectrum, lambda max = 257 nm; absorbance, E1cm1% (257 nm) = 723; infrared spectrum, same as that of USP Reference Standard of Tolnaftate; melting point, 112.1 degrees C; thin-layer chromatography, no impurities were detected until 500 micrograms; high-performance liquid chromatography, no impurities were detected; loss on drying, 0%; water, 0.01%; assay, 100.4% by absorbance method and 100.1% by the HPLC method in terms of the USP Reference Standard. Based on the above results, this raw material was authorized to be the Reference Standard of the National Institute of Hygienic Sciences.