Commentary

A critical assessment of the ICH guideline on photostability testing of new drug substances and products (Q1B): Recommendation for revision

  1. Steven W. Baertschi1,*,
  2. Karen M. Alsante2,
  3. Hanne H. Tønnesen3

Article first published online: 4 FEB 2010

DOI: 10.1002/jps.22076

Issue

Journal of Pharmaceutical Sciences

Journal of Pharmaceutical Sciences

Volume 99, Issue 7, pages 2934–2940, July 2010

Additional Information

How to Cite

Baertschi, S. W., Alsante, K. M. and Tønnesen, H. H. (2010), A critical assessment of the ICH guideline on photostability testing of new drug substances and products (Q1B): Recommendation for revision. Journal of Pharmaceutical Sciences, 99: 2934–2940. doi: 10.1002/jps.22076

Author Information

  1. 1

    Eli Lilly and Company, Analytical Sciences Research and Development, Lilly Research Laboratories, Indianapolis, Indiana 46285

  2. 2

    Pfizer Global Research & Development, Analytical Research & Development, Eastern Point Rd., Box 4077, Groton, Connecticut 06340

  3. 3

    Department of Pharmaceutics, School of Pharmacy, University of Oslo, PO Box 1068, Blindern, 0316 Oslo, Norway

*Eli Lilly and Company, Analytical Sciences Research and Development, Lilly Research Laboratories, Indianapolis, Indiana 46285. Telephone: 317-276-1388; Fax: 317-277-2154.

Publication History

  1. Issue published online: 23 APR 2010
  2. Article first published online: 4 FEB 2010
  3. Manuscript Accepted: 4 DEC 2009
  4. Manuscript Received: 20 NOV 2009

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Keywords:

  • physical stability;
  • chemical stability;
  • analytical chemistry;
  • stability;
  • solid state stability

Abstract

The ICH guideline on photostability (ICH Topic Q1B) was published in November 1996 and has been implemented in all three regions (US, EU, and Japan). The guideline describes a useful basic protocol for testing of new drug substances and associated drug products for manufacturing, storage, and distribution, but it does not cover the photostability of drugs under conditions of patient use. The pharmaceutical industry now has considerable experience in designing and carrying out photostability studies within the context of this guideline, and issues have been identified that would benefit from the revision process. The purpose of this commentary is to accomplish the following: (i) highlight issues proposed for consideration in the ICH revision process, (ii) offer a rationale for why these issues may compromise the design of a testing protocol and/or the results of the testing program, and (iii) provide recommendations for clarification of the guideline. © 2010 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 99:2934–2940, 2010

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