Knowledge Center
Photostability studies of drug substances and products
The authors studied the photostability characteristics of a drug substance and its formulated product according to the conditions proposed ICH's guideline on photostability. Two photostability apparatuses were designed on the basis of Option 2 recommendations. The results indicate that the conditions provide insufficient details to ensure reproducibility. The current ICH recommendations are subject to different interpretations and therefore need further improvements and better standardization.