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

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青云之上 一阶会员 用户来自于: 广东省深圳市
2023-10-24 20:58

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A number of users had informed us that regulatory requirements in their country permit the use of withdrawn reference standards (and therefore the corresponding monographs), even after their official withdrawal date.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


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2023-10-24 20:58
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