EP问答 41-51 完

julia朱玉姣

41. In chapter 2.5.12, how doI proceed if the water content of my sample is below 2.5 mg? 在2.5.12章中，如果我的样品里水含量小于2.5mg，我要怎么往下做呢？

The method described in chapter 2.5.12 is suitable forwater contents between 2.5 and 25 mg. If your sample contains less than 2.5 mgof water, you can add a known amount of water so that the total amount of wateris within the indicated limits. If you decide to use the micro-determination2.5.32, this would be regarded as an alternative method and it would have to becross-validated accordingly, unless it is described in the monograph.

在第2.5.12章里所述的方法适用于水分含量在2.5至25mg之间。如果你的样品含水低于2.5mg，你可以增加已知数量的水，让水的总数量在所指的限度内。如果你决定使用微量测定法2.5.32，则会被当作是替代方法，必须相应地做交叉验证，各论里另有描述者除外。

42. In chapter 2.5.12, what solvent should I use for thewater determination? 在2.5.12章中，在测定水时我要用什么溶剂？

Usethe solvent indicated in the monograph or recommended in the Knowledge database. Alternatively, methanol R or the solventrecommended by the supplier of the titrant may be used, provided that thesuitability requirements are fulfilled.
使用各论中所给定的溶剂，或者在知识数据库里推荐的溶剂。如果满足适用性要求的话，也可以使用试剂级甲醇，或者供应商推荐的溶剂。

43. How can I perform thesuitability test described in chapter 2.5.12.?  我要如何实施第2.5.12中所述的适用性测试？

You may proceed as described below. The sequentialadditions are about the same size for each step, which usually corresponds toabout 50 to 100 percent of the amount found in the sample.

你可以按下述方法进行。

1. Titrate the sample (M mg of water).

样品滴定(M mg水)

2. Add the first amount of water (x1 mg). Titrate (y1mg).

第一次加入水(x1 mg). 滴定 (y1 mg)

3. Add the second amount (x2 mg). Titrate (y2 mg).

第二次加入水(x1 mg). 滴定 (y1 mg)

4. Add the third amount (x3 mg). Titrate (y3 mg).

第三次加入水(x1 mg). 滴定 (y1 mg)

5. Add the fourth amount n (x4 mg). Titrate (y4 mg).

第四次加入水(x1 mg). 滴定 (y1 mg)

6. Add the fifth amount (x5 mg). Titrate (y5 mg).

第五次加入水(x1 mg). 滴定 (y1 mg)

7. Calculate the recovery r for each addition and themean recovery.

计算每次加入水的回收率r以及平均回收率

8. Calculate the regression line for the data wherethe cumulative water added (X1=x1; X2= x1 + x2; X3=x1 + x2 + x3; X4=x1 + x2 +x3 + x4; X5= x1 + x2 + x3 + x4 + x5) on the x-axis is plotted against the sumof the initial water content determined for the substance (M) plus thecumulative water determined (Y1=M + y1; Y2=M + y1 + y2; Y3=M + y1 + y2 + y3;Y4=M + y1 + y2 + y3 + y4; Y5= M + y1 + y2 + y3 + y4 + y5) on the y-axis.

计算数据线性回归，

X轴为累计加水量(X1=x1; X2= x1 +x2; X3=x1 + x2 + x3; X4=x1 + x2 + x3 + x4; X5= x1 + x2 + x3 + x4 + x5)

Y轴为初测物质含水量加上测得累计水量(Y1=M + y1; Y2=M+ y1 + y2; Y3=M + y1 + y2 + y3; Y4=M + y1 + y2 + y3 + y4; Y5= M + y1 + y2 + y3+ y4 + y5)

Calculate the slope (b), the intercept with the y-axis(a) and the intercept of the extrapolated calibration line with the x-axis (d)(which is always negative), and the percentage errors (e1 and e2).

计算斜率(b)，Y轴截距(a)和X轴截距(d)（永远是负的），百分比误差（e1和e2）。

In an ideal case a and │d│ are equal to M.

在理想情形下，a和│d│等于M。

44. Does the suitabilityrequirement described in chapter 2.5.12 apply to both method A and B?  在第2.5.12章中所述的适用性要求是否适用于方法A和B？

The proposed method is a suitable approach for methodA, but others are possible. No approach for method B is given in the text.

所拟的方法对于方法A来说是适用的，但其它的也可能适用。对于方法B，在文中并未给出方法。

45. Does the suitability testdescribed in chapter 2.5.12 have to be run every time? 在第2.5.12中所述的适用性测试是否每次都要做？

The suitability test has to be carried out only oncefor each combination of commercial titrant/substance to be examined. If thesuitability has been checked by the reagent supplier, it is not necessary torepeat the test. There is no need to repeat the test for a new batch of substanceor titrant.

适用性测试只要做一次，就是在将商业滴定剂和待测物质联合应用时。如果试剂供应商已经检查过适用性，则不需要重复这个测试。新的物质批准和新的滴定剂批号不需要重复该测试。

46. When should I apply Chapter 2.9.40 ‘UNIFORMITY OFDOSAGE UNITS’? 什么时候我应该使用第2.9.40章“剂型均一性”？

Froma pharmaceutical quality point of view, the approach taken in the harmonisedgeneral chapter on uniformity of dosage units (2.9.40) is considered equivalentto what was required in general chapters 2.9.5 and 2.9.6. Thus, the decision onwhat approach to take is left to the user. Either 2.9.40 or 2.9.5 and 2.9.6 maybe applied to demonstrate compliance with the Ph. Eur. with regard to theuniformity of dosage units.
从药品质量的观点来说，在协调过的剂型均一性通则（2.9.40）中所采用的方法被认为是等同于通则2.9.5和2.9.6的要求。因此，用户可以自行决定采用何种方法。通则2.9.40和2.9.5及2.9.6都可以用来证明符合EP的剂型均一性要求。
Formore details, you can also consult the Questions & Answers provided by theQuality Working Party of the European Medicines Agency on their website
更多细节，你可以参见EMA质量工作组在其网页上公布的问答。

47. In Chapter 2.6.12 undersection 4-4 ‘GROWTH PROMOTION OF THE MEDIA’, there is a statement that reads“For solid media, growth obtained must not differ by a factor greater than 2 fromthe calculated value for a standardised inoculum’’. Does the statement meanthat the difference can be twice or half the calculated value ofinoculum? 在2.6.12章第4-4部分“培养基促生长试验”中，有一个声明说“对于固体培养基，所获得的生长情况与标准接种物计算值差异级别不得大于2”。该说明是讲差异可以是接种物计算值的两倍至一半吗？

Your interpretation is correct. If the inoculum is 100CFU, then the recovery must be between 50 and 200 CFU.

你的理解是正确的。如果接种物是100CFU，则回收率必须在50-200CFU之间。

48. Frequently asked technical questions about theharmonised Microbiology Chapters 2.6.12 and 2.6.13: ‘‘Can I use other strainsthan those cited in the European Pharmacopoeia? What is the purpose of thenegative control? What does the factor 2 mean? Why are bacteria counted as partof TYMC? etc...’’  关于协调后的微生物章节2.6.12和2.6.13常见技术问题：“我可以用不同于EP里所指的其它菌种吗？阴性控制的目的是什么？系数2表示什么？为什么细菌计数作为TYMC的一部分？等等……”

Inresponse to the high number of questions raised on these chapters, a detailedformulary is now available in the KnowledgeDatabase
为了回应关于此章节的大量问题，有一份详细的表格现在公布在知识数据库里可以找到。
Onceyou are in the database, in the drop-down menu select "search anumber" and type “20612” or “20613”. Then click "additionalinformation".
进去数据库后，在下拉菜单里选择“搜索数字”，原来输入“20612”或者“20613”，然后点击“更多信息”。

49. Should we use “sulf...” or“sulph...” for our substance in English? 我们物质写成英文时是应该用“sulf-”还是应该用“sulph-”？

At its June 2009 meeting, the European PharmacopoeiaCommission has decided to apply IUPAC and WHO INN rules. Therefore the spelling“Sulfate” instead of “sulphate” will be used in the 7th edition of the EuropeanPharmacopoeia.

在2009年6月的会议上，EP委员会已经决定应用IUPAC和WHO INN命名规则。因此，在EP第7版里开始使用“sulfate”替代“sulphate”。

This change has been made for consistency purposesonly and will have no impact on the level of quality required for activesubstances or excipients to be used in medicinal products.

此变更仅是为了协调一致，不会对药用活性物质或辅料的质量水平要求产生影响。

There will be a transition period, where the spellingcould differ from the official European Pharmacopoeia name.

期间会有一个过渡阶段，拼写可以与EP中的正式名称不同。

During this transition period name changes will occur:

在过渡阶段，当以下情形发生时将会变更名称：

Ÿ  For Certificates of Suitability when new revisions or renewals aregranted;

Ÿ  CEP修订或更新重新颁发时

Ÿ  For Reference Standards when new/replacement batches of are released.

Ÿ  对照品发行新批号或替换时

50. I have a questionregarding the revision of the general chapter ''3.2.1 glass containers for pharmaceuticaluse''.  我对通则“3.2.1药用玻璃容器”修订有问题

You can contact the EDQM by clicking on the linkbelow.

你可以点击以下链接联系EDQM。

51. My question about the content of the EuropeanPharmacopoeia monographs and General Chapters is not in the FAQs, therefore Iwould like to contact the EDQM. 我有关于EP各论和通则内容的问题，但不在FAQ里面，所以我想联系EDQM。

Youcan contact the EDQM by clicking on the link below.
你可以点击以下链接联系EDQM。
Forinformation on how to use the HelpDesk, please see Topic 11 or consult the HelpDesk User Manual

关于如何使用帮助桌面，请参见主题11或者参考帮助桌面用户手册。

lov_new

非常好的资料。
EP问答回答的人是EP药典委的专家吗

chenjiao501

谢谢分享  

xhf123456

谢谢分享

julia朱玉姣

lov_new 发表于 2016-7-4 08:34
非常好的资料。
EP问答回答的人是EP药典委的专家吗

是的，这是官网的问答

cuntian_wang

很好的资料，至51完整了？

julia朱玉姣

cuntian_wang 发表于 2016-7-4 15:14
很好的资料，至51完整了？

是的

joysun611

有机会的时候来听听学习学习哦！

syhorchid

谢谢分享

yanzhengren

many thanks