欧洲药典中英文翻译 EP8.0干燥失重

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2.2.32. LOSS ON DRYING 干燥失重

Loss on drying is the loss of mass expressed as per cent m/m. 干燥失重指重量损失,表述为% 重量/重量

Method. Place the prescribed quantity of the substance to be examined in a weighing bottle previously dried under the conditions prescribed for the substance to be examined. Dry the substance to constant mass or for the prescribed time by one of the following procedures. Where the drying temperature is indicated by a single value rather than a range, drying is carried out at the prescribed temperature +/- 2?C.

方法:将要求数量的待检样品放置于预先干燥的称量瓶中,按要求条件进行干燥,直至样品干至恒重或下述程序指定的时长。如果干燥温度给定的是一个值而不是一个范围,则在指定温度+/- 2?C进行干燥。

a) “in a desiccator”: the drying is carried out over diphosphorus pentoxide R at atmospheric atmostpheric pressure and at room temperature;

在干燥器中:指在室温常压下,用五氧化二磷试剂,进行干燥

b) “in vacuo”: the drying is carried out over diphosphorus pentoxide R, at a pressure of 1.5 kPa at room temperature;

真空:在室温下,真空1.5kPa下,用五氧化二磷试剂进行干燥

c) “in vacuo within a specified temperature range”: the drying is carried out over diphosphorus pentoxide R, at a pressure of 1.5kPa to 2.5kPa within the temperature range prescribed in the monograph;

在指定温度范围内真空下:真空1.5kPa2.5kPa下,各论要求的温度范围内,用五氧化二磷进行干燥

d) “in an oven within a specified temperature range”: the drying is carried out in an oven within the temperature range prescribed in the monograph;

在烘箱里指定温度下:在各论要求的温度范围内,用烘箱进行干燥

e) “under high vacuum”: the drying is carried out over diphosphorus pentoxide R at a pressure not exceeding 0.1kPa, at the temperature prescribed in the monograph.

在高真空下:在各论要求的温度下,不超过0.1kPa的真空下用五氧化二磷进行干燥 If other conditions are prescribed, the procedure to be used is described in full in the monograph.

如果需要采用其它条件,则在各论中应进行详细描述。




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