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杂质方法学研究 英文39

发布者: lorespirit | 发布时间: 2012-8-25 10:08| 查看数: 601| 评论数: 0|

Accuracy

Definition: The accuracy of an analytical procedure expresses the closeness of

agreement between the value that is accepted either as a conventional true value

or as an accepted reference value and the value found.

General Considerations

Range.Accuracy for the area percent method should be established from 50%

of the ICH reporting limit to the nominal concentration of drug substance in

the sample solution. For the high–low and external standard methods, deter-

mine accuracy from 50% of the ICH reporting level to 150% of the proposed

shelf life specification of the related substances. In addition, for the area percent

and high–low methods, it is necessary to determine the accuracy of the related

substances and the drug substance. For the external standard method, only the

accuracy of related substances is required. Since the response of the drug sub-

stance in the sample solution is not used in the external standard calculation, it

is not necessary to determine accuracy for the drug substance.

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