请教关于EP的阿卡波糖对照品使用

loveaysl

1.这个对照品含量是指每瓶含主成分94.2mg？国外的分装技术，可以保证这么精确了么。

2.使用方法是将溶剂直接注入对照品瓶中溶解，不需要进行称量操作，直接将溶解后溶液进行转移稀释么？

3.我们使用EP对照品检测含量，跟使用中检院对照品相比，样品含量低了2个点左右，EP对照品检测比较接近理论值，这种情况怎么处理呢。

loveaysl

1. Identification
Catalogue code: Y0000500 Unit Quantity: ca 100 mg
2. Scientific Information
2.1 Intended use
Reference Standard for laboratory tests as prescribed in the European Pharmacopoeia only.
Established for use with the monograph(s): 2089.
2.2 Analytical information related to intended use, when applicable
The “as is” content is : 94.2 mg C25H43NO18 per vial
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.
2.4 Validity
A statement on the validity of the batch (Batch Validity Statement) can be printed directly from the
EDQM website (Reference Standards Database).
2.5 Instructions for use
Allow the closed container to equilibrate at ambient temperature before breaching to avoid uptake of
moisture.This substance has been freeze-dried and is known to be hygroscopic. Tap the container
gently to collect the material at the bottom. Reconstitute the contents by injecting a suitable volume
of the solvent. Mix gently to ensure complete dissolution. When necessary transfer the solution to an
appropriate volumetric flask and dilute to the required concentration. Once the container has been
breached, stability of the contents cannot be guaranteed. It is for immediate use.

henryizhao

1.看描述是这个意思。不一定是分装的固体粉末啊，有可能是分装液体，再冻干，取液体的体积应该能取的比较准吧

2.是的

3.我看中检院的阿卡波糖说明书，需要临用自测水分含量，测了吗？

loveaysl

henryizhao 发表于 2022-4-20 14:19
1.看描述是这个意思。不一定是分装的固体粉末啊，有可能是分装液体，再冻干，取液体的体积应该能取的比较准 ...

谢谢老师，中检院的对照品测了水分的

henryizhao

一般来说，药典对照品是用在相应药典方法上的

在其他方法上用药典对照品，需要自证适用性

有可能某些该分开的杂质和主峰一块儿出峰，从而影响含量赋值的准确性


但是吧~我觉得中检院的对照品每次用都要测水分，而且吸湿性太强，使用起来比较麻烦，也容易造成误差，我会首选EP对照品~

loveaysl

henryizhao 发表于 2022-4-21 09:00
一般来说，药典对照品是用在相应药典方法上的

在其他方法上用药典对照品，需要自证适用性

谢谢老师，那我们再用两种对照品测下有关物质，做个对比看看结果。

henryizhao

loveaysl 发表于 2022-4-21 12:04
谢谢老师，那我们再用两种对照品测下有关物质，做个对比看看结果。

不客气

我只是随便举了个例子，不一定就是原因所在