Journal article Open Access
Ware Agasti L.*, Pekamwar S.S.1
The identification, characterization and control of both the processes and degradation related impurities in Active Pharmaceutical Ingredients (APIs) or drug substances are the essential aspects of drug development2,3,4. Complete elimination of impurities for safe human consumption has been the goal of both pharmaceutical companies and various regulatory agencies1. Consequently, for any drug registration, one of the principal requirements is to specify both identified and unidentified impurities in drug substance/drug product as per ICH guidelines Q3A(R), Q3B(R) and Q3C 6. Characterization of impurities is required, particularly when they are present at a level higher than the identification threshold to control their levels in the final API or drug product1,6.