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The raw material for cholecalciferol was tested for preparation of the "Cholecalciferol Reference Standard (Control 921)". Analytical data obtained were as follows: melting point, 89.9 degrees C; UV and infrared spectra, the same as those for JP Cholecalciferol Reference Standard (Control 901), respectively; specific absorbance at 265 nm E1%1 cm = 472.2; optical rotation, [alpha]20D = 107.1 degrees; thin-layer chromatography and high-performance liquid chromatography (HPLC), no impurities were detected; assay, 99.97% by HPLC. Based on the above results, the raw material was authorized as the Japanese Pharmacopoeia Reference Standard (Control 921).
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