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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 382 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...
29 July 2018 3,015 7 View
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...
13 August 2017 4,194 13 View
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...
26 October 2016 8,813 3 View
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...
19 August 2015 4,469 19 View
If I want to use compenidal HPLC assay method for a drug product stability testing, what parameters should I test when performing method verification? Is it including specificity?
30 July 2015 6,764 2 View
Hi everybody...Regarding forced degradation and HPLC method development, should mass balance be considered to get a valid stability-indicating method?
28 July 2015 2,529 7 View
