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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:


 



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

Leveraging our knowledge of organic chemistry, coupled with our access to online chemistry research databases, We can: