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杂质方法学研究 英文18

发布者: lorespirit | 发布时间: 2012-8-24 12:14| 查看数: 852| 评论数: 1|

METHOD VALIDATION EXPERIMENTS

In this section we outline the requirements for method validation according to

current ICH guidelines.

Specificity

ICH definition: Specificity is the ability to assess unequivocally the analyte in the

presence of components that may be expected to be present.

Most related substance methods will be used in a stability study, and therefore

they have to be stability indicating. Stability indicatingmeans that the method

has sufficient specificity to resolve all related substances and the drug substance

from each other. Typically, for the related substance method for a drug product,

degradation products are the most critical related substances. Therefore, as a

minimum requirement, the method should have sufficient specificity to resolve

the degradation products and the drug substance. In addition, all degradation

products should be resolved from potential interference with the excipients.

最新评论

pansy77 发表于 2015-6-4 18:25:53
Thank you for your sharing.
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