【求助】lot uniformity,contents

我的理解是大样品的均一性检测和标准目录，请看下面一段对话：

Lot uniformity testing
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I'm curious to know if companies are performing lot uniformity testing on clinical lots where dissolution testing is collected in addition to the standard content uniformity test. If so, how many dosage units are collected and at what interval in the manufacturing run. Beginning, Middle, End? or every 15 minutes? or some other means of subdivision?

Also, how are specifications applied. For example, if a beginning, middle and end sample are pulled, is the spec applied individually to each pull or is the spec applied to all dosage units from the 3 pulls? Do you set another spec that evaluates the uniformity among a beginning, middle or end sample regardless or whether or not it meets the Q value?

I have worked for three different pharmaceutical companies. In each of these companies samples which were taken across the compression run were tested for active ingredient content only. The purpose of this study is to determine if segregation of the active ingredients occurs during the tableting process. Dissolution was not performed.

We typically performed dissolution profiles during our process characterization on 6 tablets for compression hardness vs dissolution looking at different press speeds as well as hardness ranges. We would also compare blending time after lubrication addition vs dissolution. In this case over blending can cause waterproofing of the granules and reduce dissolution of the final compressed tablets.

In any case the specifications should be applied to each data set indivdually. One should also compare the data to look for trends.
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Steve Mayock
Catalent Pharma Solutions
Stability Services
919-465-8280

I worked for a company were we did perform the dissolution testing in addition to the content uniformity during clinical trials. I have tested the dissolution on beginning, middle and end samples to show that the dissolution is not effected during the tabletting process. We treated the testing both individually and as composite of all three tests for comparative purposes.
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John

应该是批次间的一致性，这里的contents是否是指药物成分含量？？

我觉得是

对于原料药,如果存在混批的情况,一般要求做混批后的均一性验证,但没见过原料药的检测项目中有Lot Uniformity检测的.有点让人费解

对于药品生产不懂,不能乱发议论。请问药品原料药只要是同一批次生产就一定具有均一性吗？

均一性应该是在不同批次间的吧？