EP8.5 2.2.32干燥失重（修订）

EP8.5 2.2.32干燥失重（修订）  

2014-12-15 20:47:13|  分类： EP|

7/2015:20232

来源：http://zhuyujiao1972.blog.163.com/blog/static/986947272014111534955954/

2.2.32. LOSS ON DRYING 干燥失重

Loss on drying is the loss of mass expressed as per cent m/m.

干燥失重是失去质量，表达为%m/m。

Method. Place the prescribed quantity of the substance to be examined in a weighin 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：将指定数量的待测样品放置在经指定待测物质干燥条件预先干燥的称量瓶中，将待测样品干燥至恒重，或根据以下程序干燥指定时长。如果干燥温度为单值，而不是一个范围，则在指定温度+/-2?C下进行干燥。

a)       “in a desiccator”: the drying is carried out over diphosphorus pentoxide R at atmospheric pressure and at room temperature;
“干燥器中”：采用五氧化二磷试剂干燥，大气压，室温

b)       “in vacuo”: the drying is carried out over diphosphorus pentoxide R, at a pressure of 1.5 kPa to 2.5 kPa at room temperature;
“真空下”：采用五氧化二磷试剂干燥，压力为1.5kPa-2.5kPa，室温

c)       “in vacuo within a specified temperature range”: the drying is carried out over diphosphorus pentoxide R, at a pressure of 1.5 kPa to 2.5 kPa within the temperature range prescribed in the monograph;
“在真空下指定温度范围内”：在五氧化二磷试剂上干燥，压力为1.5kPa-2.5kPa，使用各论中所述的温度范围

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; instrument qualification is carried out according to established quality system procedures, for example using a suitable certified reference material (amoxicillin trihydrate for performance verification CRS may be used);
“在指定温度范围内”：样品置烘箱中，在各论指定的温度范围内烘干；仪器应根据建立的质量体系程序进行确认，例如使用适当确认过的对照物质（可以和阿莫西林三水合物性能确认对照品）

e)       “under high vacuum”: the drying is carried out over diphosphorus pentoxide R at a pressure not exceeding 0.1 kPa, at the temperature prescribed in the monograph.
“在高真空下”：采用五氧化二磷试剂，在不超过0.1kPa下，在各论指定的温度下干燥

If other conditions are prescribed, the procedure to be used is described in full in the monograph.

如各论有指定其它方法，则应使用各论中描述的方法进行测定。