【求助】外国药典中对应“一致”之英文是什么?

都不是。。。应是compliance with吧

The Current Good Manufacturing Practice regulations [21
CFR 211.194(a)] require that test methods, which are used for assessing compliance ofpharmaceutical articles with established specifications, must meet proper standards of accuracy
and reliability.

USP 1225列子

The above seems focus on the “test method”, not particularly the requirement of “measured value” although it implies that the measured value should meet the proper accuracy.

Is there any wording equivalent to “结果的有效位数要和标准一致”?

下面是美国药典中的一种表示法,供楼主参考:

7.20. Rounding Rules
The observed or calculated values shall be rounded off to the number of decimal places that is in agreement with the limit expression. Numbers should not be rounded until the final calculations for the reportable value have been completed. Intermediate calculations (e.g., slope for linearity) may be rounded for reporting purposes, but the original (not rounded) value should be used for any additional required calculations. Acceptance criteria are fixed numbers and are not rounded.

网友hgger在http://bbs.instrument.com.cn/shtml/20100608/2599734/ 所述为 “药典明确规定了结果的有效位数要和标准一致”, 究竟中国药典中是用有效位数number of significant figures还是number of decimal places? 这是很不同的。

= = = = = =

12.5 : number of significant figures = 3
12.5 : number of decimal places = 1

我个人认为中国药典所说的有效位数是欠妥的。比方说对于相关物质，美国药典有这样的说明：
USP will express the impurity limits to two decimal place (e.g., 0.05%, 0.14%), if the limit of an impurity is below 1.0%, and to one decimal place (e.g., 1.2%) if the limit is at or above 1.0%.
如果相关物质检测出来的数据为0.00000000000000081%，标准为不大于0.05%，按中国药典的规定，结果是否就必须报告为0.0000000000000008%呢？明显没有这种必要

If I am going to measure a length in mm to 3 significant figures and 1 decimal place, a steel ruler with resolution of 1 mm will be adequate (say, 12.5 mm). If I am going to measure a length in mm to 3 significant figures and 2 decimal place (say, 4.62 mm), I have to use a caliper. But I still do not really understand the difference between the number of significant figures and number of decimal places. 最近, 发觉自己对一些基本概念其实不很明白, 看来, 要从新再学一遍了。

这个在USP哪个章节中？应该是USP33的规定吧
附件为USP赋形剂的说明，是在USP官网上的文章，同样提到了影子的说明