Nidal Batrawi

5 Questions 19 Answers 0 Followers

Questions related from Nidal Batrawi

Can acid or base hydrolysis occur in non-aqueous liquid formulations? should I perform acid/base hydrolysis in forced degradation study in such cases?

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 302 2 View

Can I use a valid published HPLC method as it is, without complete validation, just verification?

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 2,917 7 View

What is the permissible overage (excess) of API in drug product formulation?

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 3,982 13 View

Is it possible to minimize the big difference in two HPLC peaks areas in the same chromatogram?

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 4,377 19 View

Hi everybody. Regarding forced degradation and HPLC method development, should mass balance be considered to get a valid stability-indicating method?

Hi everybody...Regarding forced degradation and HPLC method development, should mass balance be considered to get a valid stability-indicating method?

28 July 2015 2,453 7 View