Send to:

Choose Destination
See comment in PubMed Commons below
J Pharm Biomed Anal. 2013 Mar 25;76:219-24. doi: 10.1016/j.jpba.2012.12.027. Epub 2012 Dec 31.

Application of iChemExplorer in pharmaceutical pH stress testing.

Author information

  • 1Analytical Development US, Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Road, CT 06877, United States.


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.

Copyright © 2012 Elsevier B.V. All rights reserved.

[PubMed - indexed for MEDLINE]
PubMed Commons home

PubMed Commons

How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Elsevier Science
    Loading ...
    Write to the Help Desk