EP问答21-30

julia朱玉姣

EP问答21-30

21. How should I prepare amore dilute volumetric solution than the one described? 我要怎么制备一个比所述的溶液更稀的滴定液？

Solutions more dilute than those described areobtained by dilution of the least-concentrated solution that is standardised.The correction factors of these solutions are the same as those from which thedilutions were prepared.

比所述更稀的溶液要由经过标定的高一个浓度的溶液来制备。这些溶液的校正因子与用来稀释的溶液相同。

22 Can the EDQM provide typical chromatograms for testsdescribed in the monographs?   

EDQM是否可以提供各论中所述的检测的典型图谱？

TheEDQM provides chromatograms as follows:
EDQM提供以下图谱：
1.In leaflets supplied alongside reference standards where necessary for theproper use as prescribed in a monograph. Leaflets can be downloaded from the OnlineReference Standards Database.
在各论中所述的用途所需的对照品的说明纸中会附图谱。说明纸可以从在线对照品数据库中下载。
2.In the KnowledgeDatabase wherever they are available and particularly where theyseem helpful for interpretation of a monograph, for example in the case ofdifficult separations.
从知识数据库里下载，特别是如果有助于各论诠释时，例如难以分离时。
Ifa chromatogram is not available from one of the above sources, the EDQM doesnot provide it.
如果从上述来源得不到的图谱，EDQM不会提供。

23 I have observed a slightdifference in retention times/retardation factors compared with the monograph.What deviation is considered acceptable? 我发现相比于各论，保留时间/延迟因子有些许差异。什么样的偏差是可以接受的呢？

The retention times, relative retentions andretardation factors are normally not part of the system suitability criteria;they are given for information only and are not mandatory. Therefore, nodeviation allowance is defined. In any case, the system suitability defined inthe monograph has to be satisfied in order to proceed with the testing.

保留时间、相对保留和延迟因子一般并不是系统适用性标准的一部分，他们是仅供参考的信息，并不是强制的要求。因此，并没有定义偏差允许程度。不管怎样，必须符合各论里给定的系统适用性要求，才可以继续检测。

24 What is the limit forspecified/unspecified/unknown impurities? 已知/未识别/未知杂质的限度是什么？

Unless otherwise prescribed or justified andauthorised, organic impurities in active substances are to be reported,identified wherever possible, and qualified as indicated in general monograph2034, Substances for pharmaceutical use (Table 2034.-1 or Table2034.-2).

除另有规定或者判定和授权外，原料药里的有机杂质要按通论2034“药用物质”（表2034-1或表2034-2）的要求进行报告、可能时鉴定，并定性。

Generally, specified impurities have their ownspecific acceptance criterion in the monograph. For other impurities, thedecision tree in general chapter 5.10, Control of impurities in substancesfor pharmaceutical use may be used to determine the applicable acceptancecriterion.

一般来说，在各论中已知杂质具有其自身特定的可接受标准。对于其它杂质，可以使用通则5.10“药用物质中杂质控制”的决策树来确定适用的可接受标准。

25 How to determine the totalimpurities? Which peaks can be disregarded? 如何确定总杂质？哪些峰可以忽略？

In chromatographic tests, the disregard limit isdefined as the nominal content at or below which peaks/signals are not takeninto account for calculating a sum of impurities. The numerical values for thedisregard limit and the reporting threshold are usually the same.

在色谱测试中，忽略限定义为等于或低于不需要计入杂质总计的峰/信号的名义含量。忽略限和报告阈的数值通常是相同的。

Peaks corresponding to the blank can also bedisregarded, as well as other peaks that the monograph explicitly states are tobe disregarded.

与空白相对应的峰，以及各论明确声明可以忽略的峰也可以忽略。

In other words, if impurities (specified orunspecified) are above the disregard limit, they should be taken into accountfor the calculation of the total impurities.

换句话说，如果杂质（已知或未鉴定杂质）超出忽略限，则在计算总杂时要考虑进去。

26 The limit for unspecifiedimpurities in the monograph is higher than the values defined in generalmonograph 2034, Substances for pharmaceutical use (Table 2034.-1) and generalchapter 5.10, Control of impurities in substances for pharmaceutical use. 各论里未鉴定的杂质限度高于通论2034“药用物质”（表2034-1）和通则5.10“药用物质里杂质控制”里定义的值。

Some monographs are awaiting revision. However, therequirements of the general monograph are binding and must be implemented bythe user as described in general chapter 5.10. In some exceptional cases, therequirements of general monograph 2034 and general chapter 5.10 do not apply,and different thresholds can be prescribed. In this case, the followingstatement can be found in the related substances section: “The thresholdsindicated under Related substances (Table 2034.-1) in the general monograph Substancesfor Pharmaceutical use (2034) do not apply”.

一些各论等待修订。但是，通论里的要求是强制的，用户必须符合通则5.10里的要求。在一些例外情形下，通论2034和通则5.10的要求不适用，可以制订不同的阈值。在此情形下，在相关物质部门可以找到以下声明“不适用通论药用物质中在相关物质项下给定的阈值（表2034-1）”。

27 How are limits forimpurities defined in monographs? 在各论里的杂质限度是如何定义的？

Limits are based on batch data that reflect the purityof the substance currently on the European market and are not higher than thelimits approved during the marketing authorisation process.

限度是基于反映当前欧洲市场上物质纯度的批数据，不高于上市许可流程中所批准的限度。

28 I observe baselineseparation when the monograph describes a peak-to-valley ratio. 我这里是基线分离度，但各论描述的是峰谷比。

Even though a peak-to-valley ratio cannot becalculated in this case, the requirement is fulfilled as the separation is evenbetter than what the monograph prescribes.

即使在此情形下不能计算峰谷比，还是满足要求的，因为分离度比起各论所述的更好。

29 I cannot achieve the systemsuitability or signal-to-noise criteria with the described chromatographicmethod. Can I make any adjustments? 我不能达到色谱方法里所述的系统适用性或信噪比标准，我能做出调整吗？

Please consult General Chapter 2.2.46, section“Adjustment of chromatographic conditions” for a list of acceptablemodifications. However, multiple modifications are not recommended, and in anycase, the system suitability criteria of the monograph and of chapter 2.2.46must be met.

请参考通则2.2.46章“色谱条件调整”部分里的可接受修订清单。但是，并不建议做多个修订，不管怎样，必须符合各论中的系统适用性标准和通则2.2.46的要求。

30. The monograph does notspecify a correction factor for a specified impurity. 各论并未指定特定杂质的校正因子。

If the monograph does not describe a correctionfactor, it is assumed that it is in the range between 0.8 and 1.2 and thereforeyou do not need to apply a correction factor to this impurity.

如果各论中并未给定校正因子，则假定其在0.8-1.2的范围，因此你不需要对此杂质采用校正因子进行计算。

w616

非常实用！
Thank you Julia

syhorchid

了解一下

cindychujiajia

太好了，很有用谢谢

兰卡威

相关物质部门......
很好，很实用。

xhf123456

学习一下

joysun611

有机会的时候来听听学习学习哦！

清风化雨

谢谢!!