EDQM对照品含量查询

15715606201 · 发表于 2022-10-9 11:51:00

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本帖最后由 15715606201 于 2022-10-9 11:51 编辑

请教各位大佬，采购EDQM的核黄素磷酸钠对照品用于含量测定用，但是查询不到对照品含量，请问能否帮忙查询一下

火舞精灵 · 发表于 2022-10-9 13:51:57

按100%计算

15715606201 · 发表于 2022-10-10 07:53:49

火舞精灵发表于 2022-10-9 13:51
按100%计算

100%的纯度用于杂质对照品没问题，现在做的含量，它纯度肯定不是100%

火舞精灵 · 发表于 2022-10-10 08:53:34

2.3 Uncertainty of the assigned value, when applicable
According to ISO Guide 34 and ISO Guide 35, for this Pharmacopoeial standard the uncertainty of the assigned value is not stated since it is considered to be negligible in relation to the defined limits of the method-specific assays for which the reference standard is used. Please also refer to Ph. Eur. chapter 5.12.
这是你那个对照品说明书上的，因为赋值的不确定性，参考欧洲药典5.12
A CRS corresponding to an impurity is characterised for identity and purity. Where a CRS is used to determine the content of a given impurity, the preferred minimum content is 95.0 per cent; where this is achieved the assigned content of the CRS is not given and it is considered to be 100.0 per cent; this approximation is acceptable since there will be no appreciable effect on the determination of impurities. When this minimum content cannot be obtained, an assigned content is given to the CRS.

yurong1000 · 发表于 2022-10-10 10:55:53

按照说明书只能用于0786核黄素磷酸钠项下的有关物质检测，其含量采用的是吸光度法，原则上你如果用于含量检测的话只能自行标定，不过考虑到只有250mg量的样品。。。。。。。