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What is the meaning of “Unit Quantity”?

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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 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。


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