Tina
第11楼2007/08/23
原文中没有and。
那是否可以在满足前提条件下只选做second identification?还是如果做,只作first identification或两个全做??
cgc717
第13楼2008/12/18
请看下面一段EP6.0上关于酒精(96%)专论中的鉴别:其中相对密度的鉴别既是First identification,又是Second identification!
ETHANOL (96 PER CENT)
Ethanolum (96 per centum)
DEFINITION
Content :
— ethanol (C2H6O; Mr 46.07) : 95.1 per cent V/V (92.6 percent m/m) to 96.9 per cent V/V (95.2 per cent m/m)
at 20 °C, calculated from the relative density using the alcoholimetric tables (5.5),
— water.
IDENTIFICATION
First identification: A, B.
Second identification: A, C, D.
A. It complies with the test for relative density (see Tests).
B. Infrared absorption spectrophotometry (2.2.24).Comparison : Ph. Eur. reference spectrum ethanol(96 per cent).
C. Mix 0.1 ml with 1 ml of a 10 g/l solution of potassium permanganate R and 0.2 ml of dilute sulphuric acid R
in a test-tube. Cover immediately with a filter paper moistened with a freshly prepared solution containing
0.1 g of sodium nitroprusside R and 0.5 g of piperazine hydrate R in 5 ml of water R. After a few minutes, an
intense blue colour appears on the paper and becomes paler after 10-15 min.
D. To 0.5 ml add 5 ml of water R, 2 ml of dilute sodium hydroxide solution R, then slowly add 2 ml of 0.05 M
iodine. A yellow precipitate is formed within 30 min. General Notices
happyjyl
第14楼2008/12/18
意思是对的,但first identification和second identification规范的译法是“第一鉴别”和“第二鉴别”(见中国药典)。substance or preparation的全称是drug substance和drug preparation,分别指原料药和制剂。
影子
第18楼2008/12/22
这段话也困惑了我很久,我们的产品First identification是A、C项,Second identification是A、B、D项,由于二者有重复的项目,所以我认为应该是二者选其一,故在实际检测中选择了First identification,产品分析报告中也只列出了A、C项,倒是没有任何客户提出疑问。今天看了各位的讨论,应该算是比较清楚了