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Regarding drug product degradation, can acid or base hydrolysis occur in non-aqueous liquid formulations? If no, should I perform acid/base hydrolysis in forced degradation study of such...
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What is the permissible overage (excess) of API in drug product formulation. Is there a reference for these limits? and what about vitamins, I found some vitamins formulation containing 25% excess...
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I have HPLC method to separate two components A and B in a drug sample, in the chromatogram peak A is very small in comparison with that of B and this is somewhat uncomfortable as chromatogram...
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How can I know if the compendial HPLC assay method is stability indicating or not?
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Hi everybody...Regarding forced degradation and HPLC method development, should mass balance be considered to get a valid stability-indicating method?
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