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Questions related from Nidal Batrawi
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...
02 April 2019 317 2 View
It is well known that regulations require verification of compendial HPLC methods and full analytical validation for non compendial methods, but what about the methods published in reputable...
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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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Is there basis or regulations for the use of the chiral compounds regarding its isomeric form L, D or the racemic form DL in the pharmaceutical industry? Is there a general rule or it can be taken...
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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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Hi everybody...Regarding forced degradation and HPLC method development, should mass balance be considered to get a valid stability-indicating method?
28 July 2015 2,467 7 View