EDQM标准物质常见问题解答

发布日期:2022-08-05

前言

欧洲药品质量管理局(European Directorate for the Quality of Medicines & HealthCare,简称:EDQM)是负责起草《欧洲药典》及标准物质制备的机构,目前EDQM提供了1900多个标准物质,在购买和使用这些标准物质的过程中,经常有用户提出各种各样的问题,例如:如何从官方渠道购买EDQM标准物质、标准物质的有效期如何查找等。针对这些问题EDQM在其官网上列出了有关标准物质的常见问题与解答

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针对这一部分问答,康利华咨询进行了汇总和翻译,在此与各位分享。后续还会有USP标准物质的常见问题与解答分享,欢迎进一步关注和阅读!

翻译人员 | 刘萍、常晓伟、王亚蕊

审核人员 | 李正敏、别春春、汪传军

红色为康利华咨询翻译内容


General information on EDQM reference standards

EDQM标准物质的通用信息

What is the intended use of EDQM reference standards?

EDQM标准物质的预期用途是什么?

The EDQM reference standards (chemical substances, herbals and herbal extracts, biological preparations) are established exclusively for the intended use(s) described in the official texts of the Ph. Eur. They are officially valid for the uses prescribed in the Ph. Eur. and represent an integral and essential part of the corresponding monograph(s). Their suitability for any other use is not guaranteed and is the sole responsibility of the user. EDQM reference standards are not intended for human or animal use.

EDQM标准物质(包括化学物质、草药和草药提取物、生物制品)专门为欧洲药典正本中描述的用途而建立。它们对于欧洲药典中描述的用途是正式有效的,并且是药典相关各论中必不可少的基础,但不保证对其他用途的适用性,需要用户自行负责。EDQM标准物质不能用于人和动物。

Certificate of analysis

分析报告

The EDQM does not provide certificates of analysis for European Pharmacopoeia reference standards. The EDQM provides an information leaflet that contains all of the information needed to carry out the tests and assays described in the related monograph(s). This leaflet can be downloaded from the Ph. Eur. reference standards database.

EDQM不提供欧洲药典标准物质的分析报告,提供一个信息说明书,说明书中包含所有各论中进行检测和含量测定的所有信息。该说明书可以从欧洲药典标准物质数据库中下载。

How can I find out the expiry date of an EDQM reference standard?

如何找到某一EDQM标准物质的失效期?

No expiry date is assigned to EDQM reference standards, but they are monitored regularly. Users must ensure that the EDQM reference standard is valid at the time of use by checking the batch validity statement (BVS) available from the Ph. Eur. reference standards database. We recommend that users purchase only a sufficient amount for immediate use.

由于欧洲药典标准物质处于定期监测状态,因此未标明效期。使用人员应通过欧洲药典标准物质数据库查询批次有效性声明(BVS),从而确保EDQM标准物质使用时的有效性。建议用户只购买短期需要消耗的数量。


As a general rule, the previous batch is still valid for 6 months once a new batch has been officially implemented. Nevertheless, only the BVS should be used to check if the batch is valid at the time of use, as a shorter (or even no) validity period may be applied to a replaced batch, for example in case of a quality issue.

通常情况下,新批次正式生效后,原批次在6个月内依旧有效,然而考虑到原批次效期可能更短(甚至没有)(例如出现质量问题时)只能通过批次有效性声明(BVS)的查询确认该批次使用时的有效性。

In order to help users to fulfill their regulatory requirements, the EDQM has implemented a new policy since the publishing of Supplement 10.2 (01/07/2020).

为了帮助用户满足监管要求,自10.2版本发布以来(2020年07月01日),EDQM实施了一项新的政策。

A number of users had informed us that regulatory requirements in their country permit the use of withdrawn reference standards (and therefore the corresponding monographs), even after their official withdrawal date. To help these users, the EDQM has modified its withdrawal policy.

许多用户告知我们,他们国家的法规允许使用(从catalogue)已经撤销的标准物质(以及相关各论),在官方撤销日期之后依旧允许。为了帮助这些用户,EDQM对相应的撤销政策进行了修订。

Therefore, stocks permitting, sale of these reference standards will continue for 6 months after the official withdrawal date. Similarly, they will remain in the catalogue for a period of 12 months after this date to allow users to print the BVS and/or finalise the necessary procedures for controlled substances.

在库存允许的情况下,标准物质的订购服务将在官方撤销日期后6个月内继续进行,此标准物质相应在catalogue中保留12个月,确保批次有效性声明(BVS)的打印和/或最终明确管制物质的必要程序。

Example:

例如:

Fluoxetine hydrochloride CRS (F0253000) is used in monograph 1104. The revised monograph entered into force on 01/01/2021. Reference standard F0253000 will be available for purchase until 01/07/2021 (01/01/2021 + 6 months) and will feature in the catalogue until 01/01/2022 (01/01/2021 +1 year). Please note that although it will still be listed in the catalogue until 01/01/2022, it will not be possible to order the reference standard after 01/07/2021. This standard will thus have an end of validity on 02/01/2022. At this date, it will no longer be displayed in the catalogue and therefore can no longer be used.

标准物质盐酸氟西汀(F0253000)用于各论1104中。修订后的各论于2021年1月1日生效。标准物质F0253000在2021年7月1日(2021年1月1日+6个月)前仍可购买,并将在Catalogue中保留至2022年1月1日(2021年1月1日+1年)。需要注意的是,尽管截止到2022年1月1日,该标准物质仍出现在Catalogue中,但是在2021年7月1日之后将不能继续订购该标准物质,该标准物质将于2022年1月2日失效,同时从Catalogue中撤销此标准物质,因此不能再进行使用。

All reference standards affected by this change are mentioned in the EDQM Newsletter and more comprehensive information is provided in the detailed view of the online catalogue.

在EDQM简报中提及了所有受此次修订影响的标准物质,更详细的信息见在线目录。

Where can I find the content assigned to a reference standard used in an assay?

在哪里可以找到用于含量测定的标准物质的标示含量?

When required by the prescribed test and/or assay of the corresponding Ph. Eur. text, the content of a CRS is given in the leaflet available in the Ph. Eur. reference standards database.

当欧洲药典中规定的检测项目和/或含量测定需要某标准物质的标示含量时,此标准物质的标示含量可以在欧洲药典标准物质数据库中的说明书中找到

For impurity CRSs used for quantification in the related substances test of the corresponding Ph. Eur. monograph, the content can be assumed to be 100%, unless otherwise indicated in the leaflet.

在欧洲药典各论中有关物质定量检测中使用的标准物质,除非说明书中另有规定,含量值可以假定为100%。

In all other cases, no value is assigned and no assumption can be made on the purity or content of the reference standard.

其他所有情况下,对标准物质的纯度或含量不赋值,也不做假设。

What is the meaning of “Unit Quantity”?

“单位数量”的含义?

The reference standard label and the reference standard catalogue (“Unit quantity” heading) declare the total amount of material (active substance and excipients, if any) that has been filled in each vial or ampoule; this information is required by customs authorities. This quantity declared is an approximate figure (“ca”), so it should not be considered accurate from an analytical perspective.

标准物质标签和标准物质目录(“单位数量”标题)标明在每个小瓶或安瓿瓶中填充的物质(活性物质和辅料,如有)的总量,该信息为海关提出的要求。标明的数量为近似的数量(“ca”),因此从分析的角度看数值不够准确。

Where appropriate, and especially in the case of substances used for titration or assay, the expression of content or potency is mentioned in the leaflet, which states the amount of active substance or the activity/potency expressed in IU or Ph. Eur. Units. This information is also available in the reference standard database under the heading ‘Assigned content’.

标准物质在适当的情况下,尤其用于滴定和含量测定时,其含量或效价在说明书中以活性物质的数量或以IU或欧洲药典单位表示,可以从标准物质数据库中的“标示含量”中获得。

How are sub-batches obtained and labelled?

如何获得和标识子批次?

Sub-batches are obtained by filling containers with material from the same batch of bulk material. All necessary precautions are taken to guarantee that the quality and specifications of the sub-batches do not differ from each other.

子批次是从同一批物料包装而来。实施所有必要的预防措施确保子批次之间在质量和规格上没有区别。

Currently, sub-batches are labelled as follows: 1.1, 1.2, 1.3, etc.

当前,子批次可以按照如下原则标记:1.1,1.2,1.3等。

Previously, sub-batches were labelled as follows: 1a, 1b, 1c, etc. This classification system is gradually being replaced.

以前,子批次的标记方式为:1a,1b,1c等。这种分类系统已经逐渐被取代了。

All information given for a batch number X, such as assigned value or, applies to all sub-batches (X.1, X.2, etc.).

为批号X提供的全部信息,如赋值,适用于所有的子批次(X.1,X.2等)。

Does the EDQM provide safety data sheets (SDSs) for the standards it supplies ?

EDQM是否为其供应的标准物质提供安全数据表(SDSs)?

Safety data sheets (SDSs), where available, can be found in the following databases:

安全数据表(SDSs),如有,可在下列数据库中找到:

European Pharmacopoeia Reference Standards

欧洲药典标准物质

WHO International Standards for Antibiotics

WHO抗生素国际标准物质

WHO International Chemical Reference Substances

WHO国际化学标准物质

For more information on SDSs, please see the Safety Management System page on our website.

有关SDSs的更多信息,请参阅我们网站上的“安全管理系统”页面。

Why is the safety data sheet/statement (SDS) missing from the online Ph. Eur. reference standards database?

为什么安全数据表/声明(SDS)不在在线欧洲药典标准物质数据库上?

SDSs are not provided for material for which no hazard has been identified. The hazard status for these materials is available in the database and is also published on the shipping documents with the note: ‘Hazard: none identified’.

未识别出危害的物料没有提供SDS。这些物料的危害状态可以在数据库中找到,也可以在运输文件中注明:“危害:未识别”。

For more information on SDSs, please see the Safety Management System page on our website.

SDSs的更多信息,请参阅我们网站上的“安全管理系统”页面。

For more other information, please us via the EDQM HelpDesk. For information on how to use the EDQM HelpDesk, please see the HelpDesk User Manual.

更多其他信息,请通过EDQM帮助平台获得。如何使用EDQM帮助平台,请参照帮助平台用户手册。

Could you please explain if drying conditions are required?

能否解释一下是否需要干燥条件?

Where no drying conditions are stated in the leaflet, the substance is to be used as received.

如果说明书上未标明干燥条件,该物质可直接使用。

For a CRS with an assigned content, the stated content is expressed ‘as is’. If a CRS is dried before use, it will no longer be suitable for its intended use.

对于标明含量的标准物质,所标明的含量以“as is”表示。如果标准物质在使用前被干燥,它将不再适用于预期用途。

How is the unit quantity in a container calculated?

每一包装里的单位数量是如何计算的?

Each supplied vial contains a quantity sufficient for the use prescribed in the Ph. Eur., and is calculated accordingly. It is recommended to use the contents of a container for the same series of analysis.

单个包装包含的内容物数量(通过计算而来)足以满足欧洲药典所描述的用途,建议一个容器里的量仅用于进行同一个序列分析试验。

What are the storage conditions for EDQM reference standards?

EDQM标准物质的储存条件是什么?

EDQM storage conditions are given in the Ph. Eur. reference standards database. Products should be stored in such a way as to avoid degradation. Our storage conditions are in most cases more stringent than those described in the monograph (if any).

欧洲药典标准物质数据库给出了EDQM的储存条件。产品应以避免降解的方式储存。我们的储存条件在大部分情况下比各论描述的(如有)更加严格。

The storage conditions only apply to unopened vials. Once a vial has been opened, the stability of its content cannot be guaranteed. Therefore, the EDQM makes no guarantees concerning the continued suitability of previously opened EDQM reference standards. Decisions concerning the proper use of previously opened EDQM reference standards are the responsibility of the user.

该储存条件仅适用于未开瓶标准物质。一旦小瓶被打开,内容物的稳定性无法确保。因此,EDQM无法确保之前已经被打开的EDQM标准物质的持续适用性。用户自行负责已开口的EDQM标准物质的恰当使用。

Similarly, reference standards stored under conditions other than those specified in the Ph. Eur. reference standards database cannot be guaranteed.

同样地,标准物质未储存在欧洲药典标准物质数据库中指定的储存条件下的也