If change in specification which parameter require to do for validation? if change in chromtographic condition then which parameter? if api change then which parameter? if change composition then which parameter? if old method not work out then whicj parameter? if additional one impurity added then which parameter of validation require to do on above each conditions? elaborate separately
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In Analytical method development related substance method when did follow w/w method when did follow area normalisation method
2 Answers Dr Reddys, Sun Pharma,
what v define from IR & NMR spectroscopy ?
how to qualify the impurity?
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