[国立卫生科学研究所的麦角钙化醇对照品（对照品971）]
[Ergocalciferol Reference Standard (Control 971) of National Institute of Health Sciences].
作者信息
Iwata M, Kitajima A, Maekawa K, Saito H, Tanimoto T, Okada S
出版信息
Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 1998(116):180-2.
The raw material for ergocalciferol was examined for preparation of the "Ergocalciferol Reference Standard (Control 971)". Analytical data obtained were as follows: melting point, 116.7 degrees C; UV and infrared spectra, the same as those for JP Cholecalciferol Reference Standard; specific absorbance, E1 cm 1% = 461(265 nm); optical rotation, [alpha]D20 = +102.5 degrees; thin-layer chromatography and high-performance liquid chromatography (HPLC), no impurity was detected; assay, 102.4% by HPLC. Based on the above results, the raw material was authorized as the Ergocalciferol Reference Standard (Control 971) of National Institute of Health Sciences.
对用于制备“骨化醇对照品（对照 971）”的骨化醇原料进行了检验。获得的分析数据如下：熔点，116.7℃；紫外光谱和红外光谱，与日本药典胆钙化醇对照品的光谱相同；比吸光度，E1cm 1% = 461（265nm）；旋光度，[α]D20 = +102.5°；薄层色谱和高效液相色谱（HPLC），未检测到杂质；含量测定，HPLC法测定为102.4%。基于上述结果，该原料被批准为国立卫生科学研究所的骨化醇对照品（对照 971）。
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