Issue Date: March 7, 1996
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Quality
Status: Draft
Q1B Photostability Testing of New Drug Substances and Products
The ICH Harmonized Tripartite Guideline on Stability Testing of New Drug Substances and Products (hereafter referred to as the parent guideline) notes that light testing should be an integral part of stress testing. This document is an annex to the parent guideline and addresses the recommendations for photostability testing.
Download the Guidance Document
