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Re: Crow3 post# 12493

Friday, 06/30/2006 2:42:38 PM

Friday, June 30, 2006 2:42:38 PM

Post# of 45771
Crow,

"Start from there, and tell me that thay are not opaque or that they are. If your argument is that they are not, then tell me how Valimed, which uses UV can look inside them and test them."

I don't believe that WMFT is arguing that they don't crush the pills, what he's saying is that they don't liquify them.

That's also how I remember his post where he reported the demo in Vegas.

The fact that pills need to be crushed opens up a whole new can of worms compared to validating non-destructively using NIR.

First, crushing requires time so validation cannot be performed in real time. Second and most importantly, crushing requires that the pill be powdered to the same degree of homogeneity evey time. When UV has limited penetrability, the surface area of the sample is very important. This is especially true when it comes to validating strength where analytical repeatability comes into play.

A pill undergoing validation must be processed into a powder consistently and in the same way it was performed in preparing the sample used to capture the original spectral signature. In other words, there must be instructions for crushing pills for testing. This also creates the need to keep all the instruments used in the preparation of the sample clean and uncontaminated so that the validation test is always trustworthy.

The need to crush pills for validation isn't as simple as it may sound- liquids are much easier.

Valimed works very good for liquids.





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