老妖
第1楼2017/11/08
3.5.2 First and second identifications 第一和第二鉴别:
Certain monographs have subdivisions entitled 'Fisrt identification' and 'Second identification'. The test or tests that constitute 'Fisrt identification' maybe used in all circumstances. The test or tests that constitute 'Second identification' maybe used in pharmacies provided it can be demonstrate that the substance or preparation is fully traceable to a batch certified to comply with all the other requirements of the monograph.
某些各论中细分出了“第一鉴别”和“第二鉴别”。
“第一鉴别”的试验在任何情况下都可采用。若该产品完全可以追溯,且可以证明该产品完全符合各论中其它的规定,则可以采用“第二鉴别”。