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杂质方法学研究 英文43

发布者: lorespirit | 发布时间: 2012-8-25 10:11| 查看数: 797| 评论数: 0|

Precision

Repeatability.ICH definition: Repeatabilityexpresses the precision under the

same operating conditions over a short interval of time. Repeatability is also

termed intraassay precision.

Repeatability of a method can be determined by multiple replicate preparations

of the same sample. This can be done either by multiple sample preparations

(n = 6) in the same experiment or by preparing three replicates at three different

concentrations. In general, one should evaluate results of individual related sub-

stances, total related substances, and the consistency of related substance profiles

in all experiments. The percent RSD and confidence level of these results are

reported to illustrate the method repeatability.

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