Regulatory Submissions—API Sections

As previously mentioned, a number of regulatory agencies, worldwide, require information on the characteristics, manufacture, control, and/or stability of any investigational API intended for experimental use in man, prior to initiation of clinical trials in their country. The information required is 

General information on the compound Description of key chemical and physical properties and characteristics Proof of chemical structure List of manufacturers 

Method of manufacture (minimally a process flow diagram) 

Discussion of impurities and degradation products Anal3dical test results 

Information on the analytical reference standard Description of the container/closure system Stability data 

---