ICH Q1B Photostability testing of new active substances and medicinal products - Scientific guideline

This document provides guidance on photostability information to be submitted in the application for marketing authorisation for new active substances and associated medicinal products.

Keywords: Photostability, light, stability, active substance, finished product, quinine actinometry

Current effective version

ICH: Q 1 B: Photostability testing of new active substances and medicinal products - Step 5

Adopted Reference Number: CPMP/ICH/279/95 Legal effective date: 01/01/1998