Recent trends in product development and regulatory issues on impurities in active pharmaceutical ingredient (API) and drug products. Part 1: Predicting degradation related impurities and impurity considerations for pharmaceutical dosage forms
AAPS PharmSciTech. 2014 Feb;15(1):198-212.
doi: 10.1208/s12249-013-0047-x.
Epub 2013 Nov 27.