EP问答11-20

julia朱玉姣

续之前的EP问答1-10
原文链接 https://www.edqm.eu/en/EDQM-FAQ-and-Helpdesk-List-630.html  

11. How can I obtain the official analytical methods of theEuropean Pharmacopoeia? Could you send me a PDF file, for example?  我如何能得到欧洲药典官方分析方法？例如，你们能发给我一份PDF文件吗？

Theanalytical methods of the European Pharmacopoeia contain cross-references toeach other, therefore cannot be distributed individually. To obtain them, youneed to order the European Pharmacopoeia and its Supplements via the EDQMOnline Store.
欧洲药典分析方法包括相互之间的交叉索引，因此不能单独提供。为了获得这些分析方法，你需要通过EDQM在线商店订购欧洲药典，及其增补。

12. Can you provide details ofsuppliers of monograph substances? 你能提供各论物质的供应商详细资料吗？

The EDQM does not provide suppliers details. Supplierscan usually be found by carrying out a web search.

EDQM并不提供供应商的详细资料。供应商通常可以通过网站搜索找到。

13. When is a materialconsidered to be of pharmacopoeial quality? 什么样的物料可以认为是具备药典质量？

A material is not of Pharmacopoeia quality unlessit complies with all the requirements stated in the monograph and in any otherapplicable text (such as general chapter, general monograph, method, etc.)

如果一个物料符合各论和其它适用文本（例如通则、通论、方法等）载明的所有要求，则认为该物料具备药典质量。

14. Do I need to validate amethod that is published in the Ph. Eur.? 我是否需要验证欧洲药典里公布的分析方法？

The test methods given in monographs and generalchapters have been validated in accordance with accepted scientific practiceand current recommendations on analytical validation. Unless otherwise statedin the monograph or general chapter, validation of the test methods by theanalyst is not required. When implementing a pharmacopoeial method, the usermust assess whether and to what extent the suitability of the method under theactual conditions of use needs to be demonstrated according to relevantmonographs, general chapters and quality systems, i. e. the correct methodtransfer is the responsibility of the user.

在各论和通则里给定的分析方法已经过验证，符合可接受的科学规范和分析方法验证现行建议。除非在各论或通则里另有规定，化验员不需要进行方法验证。在实施药典方法时，用户必须评估方法的在实际使用条件下的适用程度，需要根据相关的各论、通则和质量体系进行证明，也就是说，用户有义务保证方法正确转移。

15. How can I find out which chromatography column or otherequipment or reagent was used during the development of a monograph?  我怎么能找到在各论建立期间所用的色谱柱和其它设备或试剂？

Goto the Knowledge Database. Locatethe monograph you are using and you should find this information. If theinformation is not there, please let us know and we will do our best to add itand inform you.
去知识数据库查找。找到你使用的各论，然后就能找到该信息。如果那里找不到此资料，请告诉我们，我们会尽最大努力增加此信息并通知你。

16. Do you recommend any particular reagent to be used fora monograph? 你们是否建议执行各论时使用特定的试剂？

Availabilityof reagents on the marketplace is verified during the drafting process of amonograph. If you have difficulty in obtaining a reagent from your regularsupplier, carry out a web search to find another one. The best search term isthe Chemical Abstracts Service registry number (CAS Number). These are given inthe reagent description in Chapter 4.1.1. Searches can also be made using thereagent name and any synonyms.
在各论起草的过程中，是确认过试剂是有市售的。如果你从你常规的供应商那里找到一个试剂有困难的话，在网站上搜索找另一个供应商。最好的搜索词是化学文摘号（CAS号），该号在第4.1.1章试剂描述里给出。搜索还可以使用试剂名称和其它名称。
Inprinciple, the EDQM cannot recommend commercial reagents or provide informationon potential suppliers. However, in certain cases, information on reagents thathave been successfully used are given in the Knowledge database (e.g. LC column brandnames).
原则上来说，EDQM不能推荐商业试剂，或者提供潜在的供应商信息。但是，在特定情形下，检测成功所用试剂的信息在知识数据库里给出了（例如，液相色谱柱品牌名）。

17. For how long can I store areagent or a solution before using it? 试剂和溶液在使用之前我可以存贮多久？

Unless prescribed in the monograph, the Ph. Eur. doesnot define expiry dates for the use of reagents or solutions. It is theresponsibility of the user to determine their shelf-life.

除非各论里有规定，否则EP并不定义试剂和溶液的使用有效期。用户有义务确定其货架期。

18. Can I use a reagent ormethod other than the one published in Ph. Eur.? 我能否使用不同于EP指定的试剂或方法？

The tests and assays described are the officialmethods upon which the standards of the Pharmacopoeia are based. With theagreement of the competent authority, alternative methods of analysis may beused for control purposes, provided that the methods used enable an unequivocaldecision to be made as to whether compliance with the standards of themonographs would be achieved if the official methods were used(cross-validation). In the event of doubt or dispute, the methods of analysisof the Pharmacopoeia are alone authoritative. It is not the role of the EDQM toapprove alternative methods or reagents.

所述的测试和方法是官方方法，药典以此为标准。在相关药监机构同意的情况下，可以使用替代分析方法来控制，所使用的方法必须能够清楚地证明如果使用官方方法时是否能达到各论标准（交叉验证）。如果有疑问或争议，则只有药典分析方法是权威的。EDQM没有职责来批准替代方法或试剂。

19. Can you provide relativeretentions for ‘Other detectable impurities’ cited in the Impurities section ofa monograph?  你们能否提供各论里杂质部分“其它可检出杂质”的相对保留时间？

The EDQM does not provide such information, as it isnot needed for the proper application of the monograph.

EDQM不提供此类信息，因为对于各论适当应用来说该信息是不必要的。

20. How can I standardise avolumetric solution? 我是否能够标定滴定液？

Volumetric solutions are standardised by the methodsdescribed in chapter 4.2.2. When a volumetric solution is to be used in anassay in which the end-point is determined by an electrochemical process (forexample, amperometry or potentiometry) the solution is standardised by the samemethod. The composition of the medium in which a volumetric solution isstandardised should be the same as that in which it is to be used.

滴定液应采用第4.2.2章所述方法标定。如果一个滴定液将用于检测，检测由电子化学过程来判定终点（例如，安培法或电位法），则应将溶液采用相同方法标化。滴定液标化所用的介质组份应与检测所用的相同。

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