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杂质方法学研究 英文11

发布者: lorespirit | 发布时间: 2012-8-23 20:17| 查看数: 1205| 评论数: 2|

Case 2.Linearity demonstrated from 50% of the ICH reporting limit to 150%

oftheshelflifespecificationofrelatedsubstance.Nosignificanty-intercept

is observed (Figure 3.7). In this case, a high–low calculation is more suitable, as

the response is linear only up to the shelf life specification level. Drug substance

concentration in sample solution (high concentration) should be diluted to the

linear range to obtain the low-concentration solution. Therefore, the response

of drug substance in low concentration will be within the linearity range and

suitable for calculation. Alternatively, a single-point external standard calibration

of concentration within the linearity range can also be used.

最新评论

david 发表于 2015-7-12 05:45:54
不错,谢谢!
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