How to do NMR method validation? - FDA.COMs Community Forums

Username	Post: How to do NMR method validation?
PaulS Member Posts: 177 Registered on 01-24-06	06-30-08 02:10 PM - Post#4793 In response to frankcyd Hi Frank This is not really a 21 CFR Part 11 topic unless you are relying upon electronic data. To answer your question (as a non bio chemical person) I would simply spike my bio chemical matrix with a known amount of impurity(s) and measure them with the NMR. Set a tolerance level and hey presto a validated method. Regards PaulS
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