USP41

matianmei

谁有最新USP41(USP36版）的中文译稿，自己翻译的有几处不太明白，或者是根据USP41建立的电子天平校准规程？

cph2345

论坛上连USP36都没有，你先上传一份吧。估计有人会帮你翻译。

玻璃杯

天平校准规程多得是，usp还有啥特别的？

Eleven

来嘛，翻译嘛

41 WEIGHTS AND BALANCES
The intent of this section is to bring the requirements for weights into conformity with American National Standard ANSI/ASTM E617, “Laboratory Weights and Precision Mass Standards.” This standard is incorporated by reference and should be consulted for full descriptions and information on the tolerances and construction of weights.1
Pharmacopeial tests and assays require balances that vary in capacity, sensitivity, and reproducibility. Unless otherwise specified, when substances are to be “accurately weighed” for Assay, the weighing is to be performed with a weighing device whose measurement uncertainty (random plus systematic error) does not exceed 0.1% of the reading. Measurement uncertainty is satisfactory if three times the standard deviation of not less than ten replicate weighings divided by the amount weighed, does not exceed 0.001. Unless otherwise specified, for titrimetric limits tests, the weighing shall be performed to provide the number of significant figures in the weight of the analyte that corresponds to the number of significant figures in the concentration of the titrant.
The class designations below are in order of increasing tolerances.
Class 1.1 weights are used for calibration of low-capacity, high-sensitivity balances. They are available in various denominations from 1 to 500 mg. The tolerance for any denomination in this class is 5 µg. They are recommended for calibration of balances using optical or electrical methods for accurately weighing quantities below 20 mg.
Class 1 weights are designated as high-precision standards for calibration. They may be used for weighing accurately quantities below 20 mg. (For weights of 10 g or less, the requirements of class 1 are met by USP XXI class M.)
Class 2 weights are used as working standards for calibration, built-in weights for analytical balances, and laboratory weights for routine analytical work. (The requirements of class 2 are met by USP XXI class S.)2
Class 3 and class 4 weights are used with moderate-precision laboratory balances. (Class 3 requirements are met by USP XXI class S-1; class 4 requirements are met by USP XXI class P.)2
A weight class is chosen so that the tolerance of the weights used does not exceed 0.1% of the amount weighed. Generally, class 2 may be used for quantities greater than 20 mg, class 3 for quantities of greater than 50 mg, and class 4 for quantities of greater than 100 mg. Weights should be calibrated periodically, preferably against an absolute standard weight.

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1  Copies of ASTM Standard E 617-81 (Reapproved 1985) may be obtained from the American Society for Testing and Materials, 1916 Race Street, Philadelphia, PA 19103.

hongwei2000

您的日子过得也太快了
现行USP只是每36版第一增补本
第二增补本还要在今天10月1日生效
您这都41版了

fangyuan5

你这个是USP附录41.
不说清楚害死人。

fangyuan5

USP29的附录41中文翻译的有，你参考下。

<41>  砝码与天平（译文）
本节的目的是对砝码提出符合美国国家标准ANSI/ASTM E617的要求，“实验室砝码和精密质量标准”。完整的描述和有关砝码的允许误差和结构的信息参考了这个标准1。
药典中的检测和化验要求在称量范围、灵敏度和重复性方面不同的天平。除非另有说明，化验时当物质被“精确称量”时，用于称重设备的测量不确定度（有时加上系统误差）不能超过读数的0.1% 。如果不少于十次的重复称量的三倍标准偏差除以总量的结果不超过0.001，测量的不确定度是符合要求的。除非另有约定，对于滴定限度实验，通过称重得到与滴定液溶度的有效数字的数位相一致的被分析物的有效数字的数位。
以下级别是以允许误差增加而划分的。
1.1级的砝码用于微量、高灵敏度的天平的校准。在这个级别中，从1至500mg各个标称单位砝码的相应允许误差都是5μg 。建议此级别砝码用于校准为了精确称量20mg以下重量而使用的光学天平或电子天平。
1级砝码用于高精度等级校准，可以用于称量20mg以下物体。（对于10或低于10g的砝码，级别1中的要求应符合USPXXI  M级别）
2级砝码用于内置砝码的分析天平的校准工作，以及用于日常分析工作的实验室砝码。（级别2的要求符合USPXXI  S级别）2
3级和4级砝码用于中等精度的实验室天平。（级别3的要求符合USPXXI  S-1级别；级别4的要求符合USPXXI  P级别）
选择适当级别的砝码以使允许误差不超过称重总量0.1%。通常2级砝码用于质量大于20mg的称量，3级砝码用于质量大于50mg的称量，4级砝码用于质量大于100mg的称量，砝码应定期校准，最好用专用标准砝码。
注：1、ASTM标准　E　617-81的副本（1985年被再次批准）可从实验与材料的美国协会1916 Race Street, Philadelphia, PA 19103得到。
2、注意S和P的名称不再设计砝码类别而是精确到级别，也就是说，设计限制例如材料的密度范围、比表面积、表面磨光、抗腐蚀性以及硬度。

hongwei2000

这个10月1号以后就作废了
第二增补本本章节几乎被全文修订
https://www.ouryao.com/thread-155157-1-1.html

jjb2005

hongwei2000 发表于 2013-8-28 13:58
这个10月1号以后就作废了
第二增补本本章节几乎被全文修订
https://www.ouryao.com/thread-155157-1-1.htm ...

消息挺灵通的。

晴兮灬love

努力~~各位。。。












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63401958

hongwei2000 发表于 2013-8-28 11:36
您的日子过得也太快了
现行USP只是每36版第一增补本
第二增补本还要在今天10月1日生效

你懂不懂啊。41是章节，她后面不是注明了36版么。自己不看清楚，瞎说

joshua

good, 好用

liyingnong

楼主上传一下吧，万分感谢

一笑而过52119

hongwei2000 发表于 2013-8-28 13:58
这个10月1号以后就作废了
第二增补本本章节几乎被全文修订
https://www.ouryao.com/thread-155157-1-1.htm ...

这个标准现在还是最新的么

zhangside001

谢谢楼主分享