1. Guidance for Industry, Good Manufacturing Practice Guidance for Active
Pharmaceutical Ingredients, Control of Drug Substance (ICH 3.2.S.4.5).
ICH Q7A Guideline.
2. a Guidance for Industry, Analytical Procedures
and Methods Validation. Chemistry,
Manufacturing, and Controls Documentation. U.S. Department of Health
and Human Services, Food and Drug Administration, July 2015.
3. b International Conference on Harmonization of Technical
Requirements for the Registration of Pharmaceuticals for Human Use,
Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients,
ICH Q7 Guideline.
4. Differences in binding properties of two proton pump inhibitors on the gastric H+,K+-ATPase in vivo