1
关注
543
浏览

What is the meaning of “Unit Quantity”?

您还未登录!暂时最多只可查看 1 条回答

登录! 还没有账号?去注册

青云之上 一阶会员 用户来自于: 广东省深圳市
2023-10-24 22:26

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。


关于作者

问题动态

发布时间
2023-10-24 22:26
更新时间
2023-10-24 22:26
关注人数
1 人关注

相关问题

印度AIS认证流程?
How can limits for cleaning purposes be established?
从ISO/TS16949到IATF16949,条款8.4.2.2的意图改变了吗?
2015版ISO9001标准中的“成文信息”该如何理解?
ISO 9001:2015条款审核与过程方式审核有何区别?
ISO9001内审全流程
ISF中是否要求必须存档最新的伦理委员会成员清单?
QSR 820将结合ISO 13485:2016,如何实施?
什么是 ISO 9001 认证转换流程?
ISO管理体系信息化现在发展情况?

推荐内容

What is the scope of the EDQM ISO 9001 certificate?
Where can I find the content assigned to a reference standard used in an assay?
Could you please explain if drying conditions are required?
Does the EDQM provide safety data sheets (SDSs) for the standards it supplies ?
How is the unit quantity in a container calculated?
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?
Can I use an in-house standard instead of a Ph. Eur. CRS?
How are sub-batches obtained and labelled?
What reference standards does the EDQM supply?
How can I find out the expiry date of an EDQM reference standard?