无菌粉末的内毒素干扰实验问题（高手请指教）

shevchenkozy

最近完全按照欧盟要求，利用动态浊度法对我们的一个无菌粉针样品进行了干扰实验。方案完成后，老外又提出新的要求，以下是详细内容：

1    Specificity Is ok when you perform the (ii) Test for interfering factors

2    Linearity - Range     Is ok if you perform "(i) Assurance of criteria for the standard curve (3 concentrantion, 3 replicates each). Calculate slope and RSD

3    Precision: Repatability and Intermediate precision This is not considered in the protocol. Therefore you should test 6 independent preparation from the same batch of meropenem, if is BE free, added of BE at 50% of specification and calculate BE content on each sample and RSD on the 6 preparation. For intermediate precision you should perform the same test, on the same batch of meropenem, in another day, by different analyst, maybe changing the batch of reagents ... as required by guidelines for validation. Calculate the content of BE on each preparation, the RSD and comparing the results obtained by the first analyst and the second analyst with relevant acceptance criteria.

4    Accuracy You should add known quantities of BE to meropenem and calculate the recovery, 3 concentration, 3 replicates for each. Basically the same as linearity, but here you add BE to meropenem

5    Quantitation and Detection Limit This should be calculated based on signal to noise, or experimentally or a formula where we consider the slope of the curve and the SD obtained in accuracy.

大家有什么好的建议和方法呢，来反驳他呢？在仪器确认时，这些实验已经完成，现在我是苦于没有什么可靠的资料来证明，可以不用在干扰实验时做他提出的以上几条。

shevchenkozy

没有高手帮忙吗？

zc3205

每一产品的定量分析均需要做上述内容。

xqliu

这是一定要做的，我们也面临这一问题。

yunxuan09071

感谢楼主分享