title: Application of iChemExplorer in pharmaceutical pH stress testing.
abstract: pH stress testing is an integral part of pharmaceutical stress testing and is a regulatory requirement for validating a stability indicating analytical method and elucidating degradation products and degradation pathways. This paper reports the results of an evaluation of iChemExplorer (ICE) for drug substance and drug product pH stress testing in comparison with the conventional (manual) approach. ICE is a simple and inexpensive technology, and through real case studies it was demonstrated that ICE is an efficient and "fit-for-purpose" alternative in conducting pharmaceutical pH stress testing. In addition, when using a non-isothermal ICE protocol, it is feasible to estimate the pH degradation kinetics (e.g., E(a)) using the ICE software.
authors: Analytical Development US, Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Road, CT 06877, United States. fenghe.qiu@boehringer-ingelheim.com
authors: Fenghe
authors: F
authors: Qiu
authors: Lily
authors: L
authors: Du
authors: Ashish
authors: A
authors: Soman
authors: Corinne
authors: C
authors: Jankovsky
authors: Chan
authors: C
authors: Li
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004355:Drug Stability; D005240:Feasibility Studies; D006863:Hydrogen-Ion Concentration; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D012984:Software; D013314:Stress, Mechanical; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000379:methods*
chemical_list: D004364:Pharmaceutical Preparations; D013607:Tablets