UNDERSTANDING AND PREDICTING THE DEGRADATION AND STABILITY OF DRUGS AND CHEMICALS
Developing an understanding of the stability and degradation chemistry of candidate new drug substances and products, and identifying their potential degradation products are critical activities that are carried out during the of a drug’s development.
A knowledge of a substance’s or product’s stability, chemistry and potential degradation products can help:
Understand and predict a substances toxicity profile and provide early warning of possible side effects that may be encountered in latter development stages. The International Conference on Harmonisation impurity guideline1 sets thresholds for which impurities and drug degradation products should be identified.
Identify appropriate formulation strategies that will produce stable and effective drug products, by identifying potential drug/excipient interactions
Identify and avoid potential bioavailability issues
Develop stability indication analytical methods
Identify storage conditions and packaging requirements
Determine periods of use and expiry dates
Similarly, information on the environmental fate of bulk chemicals is often required for registration and other regulatory purposes. Information about the chemical reactions of a substance is also required to reach informed conclusions about a chemical’s hazards and for creating informative material safety data sheets (MSDS).
1. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Guideline Q3B, Impurities in drug substances, 2006. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3B_R2/Step4/Q3B_R2__Guideline.pdf