Knowledge Center
Article / Jan 01, 2000
Photostability studies of drug substances and products
Source:
Pharm. Technol. (2000), 24(8), 30, 32, 34-35
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.
Also in the Knowledge Center
/ Dec 01, 2015
The importance of human factors in inhaler development: The making of PowdAir®
Read more
Scientific Article
/ Nov 26, 2015
FDA Draft Guidance for Industry: Request for Quality Metrics – FDA-2015-D-2537
Read more
Scientific Article
Scientific Article