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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

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A number of users had informed us that regulatory requirements in their country permit the use of withdrawn reference standards (and therefore the corresponding monographs), even after their official withdrawal date.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:

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.

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无法确保（其持续适用性）。

How can I obtain the impurities listed in a monograph?

如何订购各论中所列明的杂质（标准物质）？

Only those substances that are necessary for carrying out the tests prescribed in the Ph. Eur. are available. In the monograph, the names of the impurities that are available are followed by ‘CRS’. If this text is not included, the EDQM does not distribute this substance. Please consult the Ph. Eur. reference standards database.

只有欧洲药典描述的检测项目所必要的标准物质可（从EDQM）获得。EDQM只支持订购在各论中后缀为“CRS”的杂质标准物质，不支持订购没有“CRS”后缀的杂质标准物质，详情请见欧洲药典标准物质数据库。

Can I use an in-house standard instead of a Ph. Eur. CRS?

可以使用内部标准品代替欧洲药典标准物质吗？

In-house standards may be used for routine analysis, provided that they are calibrated against EDQM reference standards. For more information, see Ph. Eur. general chapter 5.12. Reference standards.

如果内部标准品使用EDQM标准物质进行了标定，可以用于常规分析。更多信息，请参阅欧洲药典5.12章<标准物质>。

How can I find a typical chromatogram of an EDQM reference standards?

如何找到某一EDQM标准物质色谱图？

The EDQM provides chromatograms as follows:

EDQM通过如下方式提供色谱图：

1）In leaflets supplied with reference standards if required for their correct use as prescribed in a monograph. Leaflets can be downloaded from the Eur. reference standards database.

标准物质附带的说明书（配合各论描述标准物质的正确使用时需要色谱图的情况下），可以从欧洲药典标准物质数据库中下载。

2）In the Knowledge database, when available and especially when they may prove helpful for interpreting a monograph (e.g. for difficult separations).

在知识数据库中（可能会提供，特别是对解释各论有帮助的情况下）（例如，需要解释色谱峰重叠的情况）

If a chromatogram is not available from one of these 2 sources, the EDQM does not provide it.

如果色谱图从这两种来源处均无法获得，（说明）EDQM不提供色谱图。

My question about the purpose and use of an EDQM reference standard is not in the FAQs - how can I contact the EDQM?

关于EDQM标准物质的目的和使用的问题未在FAQs中，应如何联系EDQM？

You can contact us via the EDQM HelpDesk. For information on how to use the EDQM HelpDesk, please see the HelpDesk User Manual.

您可以通过EDQM HelpDesk联系我们。如何使用EDQM帮助平台，请参阅帮助平台使用手册。

Ordering EDQM Reference Standards?

订购EDQM标准物质？

What reference standards does the EDQM supply?

EDQM提供哪些标准物质？

The EDQM supplies the reference standards required for the proper application of Ph. Eur. monographs. You can find the list and the availability of these standards on the Ph. Eur. Reference Standards Database (downloadable). Please note that the catalogue is updated on a daily basis, so we recommend that you to use the online database instead of the downloaded version.

EDQM提供欧洲药典各论要求的标准物质。可以在欧洲药典标准物质数据库（可下载）中找到清单和可用的标准物质。请注意该目录每天更新，因此我们建议使用在线数据库，而不是已下载的版本。

How can I find out the price, handling, storage, shipping conditions and other information related to EDQM Reference Standards?

如何找到EDQM标准物质的价格，处理，储存，运输条件及其他信息？

All relevant up-to-date information is available in the Ph. Eur. Reference Standards Database. See also Ph. Eur. General Chapter 5.12 REFERENCE STANDARDS.

所有相关的最新信息可以在欧洲药典标准物质数据库中获得。也可以参阅欧洲药典通则5.12<标准物质>。

Can I access the ''Pharmaceutical Reference Standards Official Catalogue'' on-line or receive a copy by post?

是否可以在线访问“药典标准物质官方目录”或通过邮寄获得复印件？

The EDQM does not publish a paper version of the catalogue. However, you can download the catalogue via the Ph. Eur. Reference Standards Database. Please note that the catalogue is updated on a daily basis, so we recommend that you to use the online database instead of the downloaded version.

EDQM不出版纸板的目录。但是，可以通过欧洲药典标准物质数据库下载目录。请注意目录每日更新，因此我们建议使用在线数据库，而不是已下载版本。

How can I place an order or request a quotation?

如何下单和寻求报价？

You can place an order or request a quotation via our web store. Watch this video guide for placing an order.

您可以通过我们的网上商城下单或寻找报价。观看此下单视频（视频链接：https://player.vimeo.com/video/526162027）。

Your orders and quotation requests can also be sent by email to orders@edqm.eu. Please note that your request has to be printed on your company’s letterhead and attached to your email.

您的订单和询价可以通过电子邮件发送给orders@edqm.eu。请注意，您的订单需要体现公司信息，并附在邮件中。

Please note that the name of the product, the item code as well as the number of sales units (not mg) must be clearly mentioned in your order.

请注意，您的订单中必须清晰的提供产品的名称、产品代码和销售单位数量（非mg）。

Do not submit the same order multiple times as you will be financially responsible for duplicate orders made.

不要多次提交相同的订单，因为您将对重复订单负有经济责任。

How can I become an official distributor of EDQM Reference Standards?

如何成为EDQM标准物质的官方经销商？

The EDQM does not have any official resellers. All resellers are free to sell EDQM products. However, the EDQM does not offer discounts to customers purchasing EDQM reference standards. For more information, please consult our list of known resellers.

EDQM没有任何官方中间商。所有中间商可以自行销售EDQM产品。但是，EDQM不向购买EDQM标准物质的客户提供折扣。更多信息，请查询已知的中间商清单。

Do I need an import licence or do I need to provide any special documentation when ordering EDQM reference standards?

订购EDQM标准物质时，是否需要进口许可证或提供任何特别文件?

Before you make your order, check if the local, regional or national authorities in the importing country require any specific documentation and confirm that the product you wish to order can be legally imported. All necessary documentation must be provided to the EDQM when placing your order (especially for biological products). For details related to specific countries, please consult the Ph. Eur. Reference Standards Database and the order confirmation.

在您下单之前，请确认进口国的地方、地区或国家当局是否需要任何特定的文件，并确认您希望订购的产品可以合法进口。下单时，所有必要的文件都必须提供给EDQM(特别是生物制品)。有关特定国家的详细信息，请咨询欧洲药典标准物质数据库和订单确认。

For controlled items, identified in our official online Ph. Eur. Reference Standards Database by an asterisk (“*”), you need to provide the EDQM with an import licence before we can request an export licence from the French authorities to send you the products. Please note that it can take up to 10 weeks to obtain this document.

在我们的官方线上欧洲药典标准物质数据库以星号标示( “*”)表示的管制标准物质，您需要向EDQM提供进口许可证，我们才能向法国当局申请出口许可证，向您发送产品。请注意，获取出口许可证可能需要长达10周的时间。

Note: for *ODS (ozone-depleting substances) products, please refer to the specific FAQ.

**注:关于*ODS(破坏臭氧物质)产品，请参阅具体的FAQ。**

For more information, see our document .

要了解更多信息，请参阅我们的文档。

What kind of permit do I need to order an ozone-depleting substance?

订购破坏臭氧层物质需要什么许可证?

Regulation (EC) No 1005/2009 of the European Parliament and of the Council prohibits the use of ozone-depleting substances (ODSs) within the EU. However, exemptions from this ban are granted under certain conditions for laboratory and analytical uses.

欧洲议会和理事会法规(EC) No 1005/2009禁止在欧盟内使用破坏臭氧层物质(ODSs)，然而实验室和分析用途的某些条件下，可以豁免这一禁令。

Orders for delivery within the EU: under this regulation, any EU end-user laboratory or EU internal distributor must have and provide to the European Directorate for the Quality of Medicines & HealthCare (EDQM) a valid LabODS number when ordering an *ODS reference standard (e.g. R0250000). To obtain a LabODS number, you need to register on the LabODS portal. The EDQM cannot process any orders for these products, for delivery within the EU, without a valid LabODS number.

在欧盟内交货的订单:根据本法规，任何欧盟最终用户实验室或欧盟内部分销商在订购*ODS标准物质(例如R0250000)时，必须拥有并向EDQM提供有效的LabODS编号。要获得LabODS编号，您需要在LabODS门户网站上注册。如果没有有效的LabODS编号，EDQM将无法处理这些订单。

Orders for delivery outside the EU: the export and import of ODSs are subject to licensing requirements. Licences are granted by the European Commission via the ODS Licensing System at the following address: https://ec.europa.eu/clima/policies/ozone/ods_en.

在欧盟以外地区交货的订单:破坏臭氧层物质的进出口须遵守许可证规定。欧洲委员会通过ODS授权系统进行授权，地址如下:https://ec.europa.eu/clima/policies/ozone/ods_en.

When receiving an order for an *ODS reference standard, the EDQM will automatically request an export licence. It is essential that users also check the legal status of the substances contained in this reference standard in their respective country and adhere to any administrative formalities required by the authorities.

**当收到*ODS标准物质的订单时，EDQM会自动索要出口许可证。用户必须检查本标准物质所含物质在各自国家的法律地位，并遵守当局要求的任何行政手续。**

How can we obtain a reference standard mentioned in Pharmeuropa?

我们怎样才能获得欧洲药典中提到的标准物质?

The EDQM supplies the reference standards required for the prevailing tests and assays of the Ph. Eur. The EDQM cannot supply reference standards that are only mentioned in draft monographs. The EDQM will only make reference standards available once the monograph has been published in the Ph. Eur. or, at the latest, when it has been implemented.

EDQM提供了欧洲药典规定的检测项目和含量测定所需的标准物质。EDQM不能提供仅在各论草案中提及的标准物质。EDQM只有在欧洲药典各论正式发布或被实施时才提供标准物质。

We used to order a reference standard from the EDQM, but it is no longer in the online catalogue. Can you provide it?

我们曾经从EDQM订购某标准物质，现在发现其不在在线目录中，还可以订购吗?

The EDQM supplies the reference standards required for the prevailing tests and assays of the Ph. Eur. Please check that the reference standard is still needed for the monograph in force. It is possible that the reference standard is no longer necessary for the tests and assays of the latest version of the monograph. If the reference standard is no longer in our catalogue, the EDQM cannot provide it.

EDQM提供了欧盟现行测试和分析所需的标准物质。请检查现行各论是否仍然需要此标准物质。在最新版本的各论的检测项目和含量测定中，可能不再需要此标准物质。如果标准物质不在我们的目录中，EDQM无法提供。

What quantity of products should I order?

我应该订购多少数量的产品?

We recommend purchasing only the number of units necessary for immediate use. Once a vial has been opened, the stability of its content cannot be guaranteed. Before ordering, please consult the number of vials per sales unit for each reference standard in our official online Ph. Eur. Reference Standards Database; a single sales unit may contain several vials.

我们建议只购买短期需要消耗的数量。一旦一瓶标准物质被打开，其内容物的稳定性就无法保证。在订购前，请查询我们官方在线药典标准物质数据库中每个销售单位的瓶数；一个销售单位可能包含几个小瓶。

Do I have to pay duties and taxes when ordering EDQM reference standards?

订购EDQM标准物质时，是否需要缴纳关税?

Prices are exclusive of duties and taxes. It is your responsibility to contact the national fiscal or customs authorities to pay any customs duties and taxes due.

价格不包括关税和税金。您有责任联系国家财政或海关当局支付任何应缴的关税和税款。

Are there any extra charges when ordering EDQM reference standards?

订购EDQM标准物质是否需要额外收费?

We charge a €2.50 handling and shipping charge per sales unit, regardless of where you are located in the world. This handling and shipping charge does not apply to reference spectra.

无论您位于全球何处，我们每个销售单元收取2.50欧元的手续费和运费。此处手续费和运输费用不适用于标准光谱。

Can I modify or cancel my order EDQM reference standards order?

我可以修改或取消我的EDQM标准物质订单吗?

Cancellations or modifications can only be accepted within 24 hours from when the order confirmation email is sent by the EDQM. After this time, you will not be able to modify or cancel your order and you will remain financially liable for it.

订单确认邮件由EDQM发出后24小时内，方可取消或修改。在此之后，您将不能修改或取消您的订单，并将继续承担财务责任。

Cancellation or modification requests can be sent by clicking on this link. In the subject line, please write “Cancellation” or “Modification”, followed by the order confirmation number or your purchase order number if you have not received an order confirmation.

取消或修改请求可以通过点击此链接发送。请在邮件主题栏填写“取消”或“修改”，并附上订单确认号码，如果您尚未收到订单确认，请填写您的采购订单号码。

I placed an order for EDQM reference standards, but I have not heard from you.

我下了EDQM标准物质的订单，但是一直没有收到你的消息。

An order confirmation will usually be sent to you by email within 2-3 working days, though it may take slightly longer to receive the confirmation during certain periods (such as at the beginning of the year due to our annual closure. If you believe your order has not been processed you can contact us via the EDQM HelpDesk. Do not forward us any confirmation emails or resend your order. You will be financially responsible for any duplicate orders that are processed as new orders.

订单确认书通常会在2-3个工作日内以电子邮件方式发送给您，但在某些时段（如年初）可能需要稍长时间才能收到订单确认。如果您认为您的订单没有被处理，您可以通过EDQM HelpDesk与我们联系。请勿转发任何确认邮件或重新发送您的订单。您将对作为新订单处理的任何重复订单承担财务责任。

The product I have ordered is limited, what does that mean?

我订购的商品显示数量有限，该如何理解?

When an item is out of stock, it is put on back order and delivered automatically as soon as it becomes available again, even if the item is out of stock for several months. A “prior to dispatch” note will be sent as soon as we are ready to send the item. If you do not wish to receive a separate shipment from your main order, please contact us via the EDQM HelpDesk and quote the EDQM order reference number, which you can find in the order confirmation email.

当商品缺货时，会被延迟交付，即使该商品已经缺货几个月了，当它再次有货时就会自动交付。当我们准备好发送该项商品时，一个“发送前”的通知将会被发送。如果您不希望从您的主订单外单独发货，请通过EDQM HelpDesk与我们联系，并说明EDQM订单参考编号，该编号可在订单确认邮件中找到。

The product I have ordered is out of stock, will it be put on back order?

我订购的产品已经断货了，是否会被列入延期订单?

When an item is out of stock, it is put on back order and delivered automatically as soon as it becomes available again, even if the item is out of stock for several months. A “prior to dispatch” note will be sent as soon as we are ready to send the item. If you do not wish to receive a separate shipment from your main order, please contact us via the EDQM HelpDesk and quote the EDQM order reference number, which you can find in the order confirmation email.

当一件商品缺货时，它就会被延迟交付，当它再次有货时就会自动交付，即使该商品已经缺货几个月了。一旦我们准备好发送该项目，“发送前”的通知将被发送。如果您不希望收到主订单的单独发货，请通过EDQM HelpDesk与我们联系，并引用EDQM订单号，该号可在订单确认邮件中找到。

Can I get a discount on reference standards?

我买标准物质能打折吗?

Unfortunately, the EDQM does not offer any discounts on reference standards.

很遗憾EDQM不提供任何标准物质折扣。

What should I do if I see an incorrect price?

如果我看到不正确的价格该怎么办?

If you notice a difference between the catalogue price and the price indicated on your order confirmation, please contact our sales team via the EDQM HelpDesk. For information on how to use the EDQM HelpDesk, please see the HelpDesk User Manual.

如果您发现目录价格和确认订单上的价格有差异，请通过EDQM HelpDesk联系我们的销售团队。有关如何使用EDQM HelpDesk的信息，请参阅帮助平台用户手册。

I am a reseller. Will you send reference materials directly to my customers?

作为中间商想问：EDQM会把标准物质直接寄给我的客户吗?

This is possible under certain conditions:

in accordance with our Terms & Conditions, both the invoicing and delivery addresses must be either inside or outside the European Union ; and

you accept that commercial documentation such as the order confirmation (including the price per item) will also be sent to the delivery address and the designated delivery contact person.

以下条件同时满足的前提下可以直接寄给您的客户:

根据我们的条款和条件，发票和送货地址必须在欧盟内部或外部；

您接受所有的订购交易文件，比如订单确认(包括每件商品的价格)也将发送到送货地址和指定的送货联系人。

How can I make a complaint about an EDQM reference standards order?

如何就EDQM标准物质订单提出投诉?

All complaints and claims must be made in writing and must be sent via the EDQM HelpDesk. For information on how to use the EDQM HelpDesk, please see the HelpDesk User Manual.

所有投诉和索赔必须以书面形式提出，并且必须通过EDQM HelpDesk发送。如何使用EDQM HelpDesk，请参阅帮助平台用户手册。

In order to make sure your complaint is admissible, please read the document How do I complain to the EDQM about an order. Any complaints received outside the time limit will unfortunately not be accepted.

为了确保您的投诉可行，请阅读文件“我如何向EDQM进行标准物质订货投诉”。很遗憾任何超出时限的投诉将不予受理。

My question about ordering the EDQM reference standards is not in the FAQs - how can I contact the EDQM?

关于我订购EDQM标准物质的问题不在FAQs-我如何联系EDQM?

You can contact us via the EDQM HelpDesk. For information on how to use the EDQM HelpDesk, please see the HelpDesk User Manual.

您可以通过EDQM HelpDesk与我们联系。如何使用EDQM HelpDesk，请参阅帮助平台用户手册。

Shipment of EDQM reference standards orders

EDQM标准物质订单的发货

Can I track my order of EDQM reference standards?

我能追踪到我订购的EDQM标准物质吗?

If you have provided an email address with your order, we will email you an order confirmation, usually within 2 working days. As soon as we have dispatched your order, we will send you another email with the shipping details.

Please bear in mind that shipments with dry ice are usually dispatched only on Mondays, and those with ice only on Mondays and Tuesdays. Dangerous goods are only shipped following agreement with the airline or the forwarder. Controlled substances are only shipped after all necessary documentation and authorisation have been received.

如果您已提供订单电子邮件地址，我们会在2个工作日内将确认订单通过电子邮件发给您。一旦我们发出您的订单，我们将给您发送另一封关于运输细节的电子邮件。

请记住，装有干冰的货物通常只在周一发运，而装有冰的货物则只在周一和周二发运。危险品只有在与航空公司或货代达成协议后才能装运。管制物质只有在收到所有必要的文件和授权后才装运。

I think my package has been lost. What should I do?

如果我的包裹丢了，我该怎么办?

Your order should normally arrive within 5 working days of the date of the email with the shipping details. If you have received the dispatch notice email, you can track your order (see Can I track my order?). If the tracking information shows an incorrect destination or the tracking status does not change for several days (or that the package is lost), please contact us via the EDQM HelpDesk. For information on how to use the EDQM HelpDesk, please see the HelpDesk User Manual.

您的订单通常应在收到邮寄详细信息的电子邮件后5个工作日内到达。如果您收到了发送通知的电子邮件，您可以跟踪您的订单(参见我可以跟踪我的订单吗?)如果跟踪信息显示目的地不正确或跟踪状态数天内没有变化(或包裹丢失)，请通过EDQM HelpDesk与我们联系。如何使用EDQM HelpDesk，请参阅帮助平台用户手册。

Why have I only received part of my order of EDQM reference standards?

为什么我只收到了EDQM标准物质的一部分订单?

As different products have different shipping conditions, it is not always possible to ship the entire order in the same package. For example, items requiring special packaging (ice, dry ice), dangerous goods and controlled substances will be shipped separately from other products. If this is the case, you will receive an order confirmation for each shipment type, which will specify what products should arrive in the same delivery.

由于不同的产品具有不同的运输条件，所以并不总是能够在相同的包装中运输整个订单。例如，需要特殊包装的物品(冰、干冰)、危险品和管制物质将与其他产品分开运输。如果是这种情况，您将收到针对每种装运类型的订单确认，其中将指定哪些产品应以相同的交货方式到达。

In addition, while the EDQM will do everything possible to ensure all orders are dispatched in their entirety, if quantities of EDQM reference standards are limited, the EDQM will try to dispatch orders in such a way that as many customers as possible will receive at least part of their requested quantity. If this is the case, it will be noted on your order confirmation.

此外，虽然EDQM尽可能确保所有订单整体一起分发，但如果EDQM标准物质的数量有限，EDQM将试图以尽可能多的客户将至少收到他们所要求数量的一部分的方式分发商品。此情形将会在您的订单确认上注明。

Will my order of EDQM reference standards be delivered to my office?

我订购的EDQM标准物质是否会送到我的办公室?

This depends on the type of products shipped, the shipping temperature and the country of importation. Please refer to our. To find out which products are delivered door-to-door (DAP) and which are delivered to the nearest airport with customs facilities (CIP), see the Ph. Eur. reference standards database.

这取决于运输产品的类型，运输温度和进口国家。请参阅欧洲药典标准物质数据库。了解哪些产品是送货上门(DAP)，哪些是送货到最近的机场与海关设施(CIP)。

If there are several possible airport delivery points or if the only one is located far from the delivery address, the EDQM will contact you for confirmation (unless you stated a preference in your purchase order form or on the import permit).

如果有几个可能的机场收货点，或者只有一个离收货地址较远的机场，EDQM将联系您进行确认(除非您在采购订单或进口许可证中注明了优先选择)。

Where can I find the documents I need to proceed with customs duties?

我在哪里可以找到办理关税手续所需的文件?

Copies of commercial invoices, customs invoices, dispatch notes and certificates of origin can be downloaded from the links at the bottom of the dispatch notice email.

商业发票、海关发票、发货单和原产地证明的副本可从发货通知电子邮件底部的链接下载。

A certificate of origin for each product, complying with US guidelines, can be downloaded from the Ph. Eur. reference standards database.

每种产品的原产地证明（符合美国指南），可从欧洲药典标准物质数据库下载。

Safety Data Sheets (SDS), where applicable, can be accessed via the Ph. Eur. reference standards database.

安全数据表(SDS)，在适用的情况下，可以通过欧洲药典标准物质数据库访问。

A copy of the airway bill can only be obtained on request via the EDQM HelpDesk. For information on how to use the EDQM HelpDesk, please see the HelpDesk User Manual.

可通过EDQM HelpDesk索取空运提单副本。如何使用EDQM HelpDesk，请参阅帮助平台用户手册。

All original documents (airway bills, customs invoices, dispatch notes, certificates of origin, SDS, permits) are attached to the parcel.

所有的原始文件(空运单，海关发票，发货单，原产地证明，SDS，许可证)都附在包裹中。

Can I return EDQM reference standards?

我可以退回EDQM标准物质吗?

In all cases, please contact the EDQM before shipping any product back to us.

在所有情况下，在把任何产品运回给我们之前，请先联系EDQM。

Within the EU: the EDQM does not accept return of controlled substances, dangerous goods, products shipped at controlled temperature or products with an assigned value.

在欧盟内部：EDQM不接受管制物质、危险品、在受控温度下运输的产品或具有明确特性的产品的退回。

Outside the EU: the EDQM does not accept the return of any EDQM reference standards.

欧盟以外：EDQM不接受任何EDQM标准物质退回。

Should you refuse a delivery, please contact us immediately, explaining the reason why.

如果您拒绝收货，请立即与我们联系，说明原因。

If the EDQM reference standard cannot be returned and the EDQM is not responsible for the defect, the value of the invoice will still be owed to the EDQM.

如果EDQM标准物质不能退回，而且缺陷不是EDQM导致的，EDQM不会退款。

The parcel is damaged and the vials inside are broken. What should I do?

包裹破损了，里面的药瓶也破了。我该怎么办?

File a complaint with the express courier agent or the airline immediately and then contact the EDQM to file an official complaint and obtain replacement vials.

If you did not issue a complaint on receipt of your parcel, the EDQM will not be able to send you a replacement.

立即向快递代理或航空公司投诉，然后联系EDQM提交正式投诉并获得替换药瓶。

如果您在收到包裹后没有发出投诉，EDQM将无法给您发送替换包裹。

My question about the shipment of an EDQM reference standards is not in the FAQs - how can I contact the EDQM?

我关于EDQM标准物质发货的问题不在FAQs-我如何联系EDQM?

You can contact us via the EDQM HelpDesk. For information on how to use the EDQM HelpDesk, please see the HelpDesk User Manual.

您可以通过EDQM HelpDesk 与我们联系。如何使用EDQM HelpDesk，请参阅帮助平台用户手册。

Biological reference preparations (BRP)

生物制品的标准物质

There are no FAQs on this topic for the moment, but you can submit your question via the EDQM HelpDesk. For information on how to use the EDQM HelpDesk, please see the HelpDesk User Manual.

目前没有关于这个主题的FAQs，但您可以通过EDQM HelpDesk来提交您的问题。如何使用EDQM HelpDesk,请参照帮助平台用户手册。

Establishment of chemical reference standards (CRS)

化学标准物质的建立(CRS)

How can I find out the purity of a Ph. Eur. CRS?

如何找到欧洲药典化学标准物质的纯度？

When required by the prescribed test and/or assay of the corresponding Ph. Eur. text, the content assigned 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可以找到。

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.

在相应的欧洲药典各论中，相关物质的定量检测中使用的标准物质，可以假设其含量为100%，除非有其他的说明。

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

除此之外，对标准物质的纯度或含量不赋值，也不做假设。

What is the water/solvent content of a Ph. Eur. CRS?

欧洲药典化学标准物质的水/试剂的组成是什么？

Information on water or solvent content is not required to use a CRS in a test and/or assay of the corresponding Ph. Eur. monograph.

在相应的欧洲药典各论的检测项目和/或含量测定中使用到化学标准物质时，不要求水或溶剂的组成信息。

The content assigned to some CRSs can be found in the leaflet accompanying the CRS. Water and/or solvent content are already taken into account in the leaflet.

某些CRS的含量可以在说明书中找到，水和/或溶剂的含量也在说明书中。

Should Ph. Eur. CRSs be dried before use?

欧盟药典的CRS在使用前是否需要干燥？

No, Ph. Eur. CRSs are to be used in the condition in which they are received. If a CRS is dried before use, it will no longer be suitable for its intended use.

不用，CRS按照收到时的状态使用即可。如果CRS在使用前被干燥，可能就不再适用于预期用途了。

Why are wavenumbers not stated on the reference spectrum?

为什么波数没有在标准光谱上说明？

It is not the policy of the European Pharmacopoeia to provide the wavenumbers of the bands on the infrared spectrum. Three calibration bands of the polystyrene film may be present on some spectra, to help identify the bands of the substance.

欧洲药典是不提供红外光谱上各段波数的，某些光谱上可能会出现聚苯乙烯薄膜的三个校准带，以帮助识别物质的波段。

Where can I find advice on how to establish in-house standards, secondary standards and/or working standards?

在哪里能找到怎样建立自制标准品，二级标准品和/或工作标准品的建议呢？

Some general information concerning secondary standards is provided in chapter 5.12 of the Ph. Eur. As the establishment of secondary or in-house standards is beyond the scope of the Ph. Eur., no further advice or information is provided on this matter.

欧洲药典5.12章节提供了一些关于二级标准品的一般信息，自制标准品或二级标准品的建立超过了欧洲药典的范围的，因此没有就这一问题提供进一步的建议或信息。

Additional information not provided in the leaflet accompanying a reference standard

标准物质说明书中未提及的额外信息

All information required for the intended use of a Ph. Eur. reference standard can be found either in the accompanying leaflet or in the corresponding Ph. Eur. text(s). No further analytical information (purity, content, exact composition, polymorphic form, etc.) is provided to users.

欧洲药典标准物质的预期用途所需信息均能够在随附的说明书或者相应的欧洲药典文本中找到，不会向用户提供进一步的分析信息（纯度、含量、确切成分、晶型等）。

My question about the establishment of an EDQM reference standard is not in the FAQs - how can I contact the EDQM?

我的关于建立EDQM对照品的问题不在常见问题中，我怎样才能联系到EDQM呢？

For more information on reference standards, please consult general chapter 5.12 of the Ph. Eur. You can also contact us via the EDQM Helpdesk. For information on how to use the EDQM HelpDesk, please see the HelpDesk User Manual.

关于标准物质的更多信息，请参考《欧洲药典》的5.12章节。您也可以通过EDQM HelpDesk联系我们。如何使用EDQMHelpDesk，请参见帮助平台用户手册。

我们也会持续EDQM相关动态，后续会整理更多文件内容，请大家关注“康利华咨询”微信公众号后续推送。 返回搜狐，查看更多

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声明：该文观点仅代表作者本人，搜狐号系信息发布平台，搜狐仅提供信息存储空间服务。

发布于：北京市

What is the intended use of EDQM reference standards?

EDQM标准物质的预期用途是什么？

Certificate of analysis

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？

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。

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。

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:

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？

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。

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无法确保（其持续适用性）。

How can I obtain the impurities listed in a monograph?

如何订购各论中所列明的杂质（标准物质）？

只有欧洲药典描述的检测项目所必要的标准物质可（从EDQM）获得。EDQM只支持订购在各论中后缀为“CRS”的杂质标准物质，不支持订购没有“CRS”后缀的杂质标准物质，详情请见欧洲药典标准物质数据库。

Can I use an in-house standard instead of a Ph. Eur. CRS?

可以使用内部标准品代替欧洲药典标准物质吗？

In-house standards may be used for routine analysis, provided that they are calibrated against EDQM reference standards. For more information, see Ph. Eur. general chapter 5.12. Reference standards.

**注:关于*ODS(破坏臭氧物质)产品，请参阅具体的FAQ。**