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Process Development Stage

1. Literature research, patent evaluation report.

(1) Find out as much relevant information that is already publicly available as possible.    
(2) Design multiple possible synthesis routes.    
(3) Evaluate whether there is intellectual property risk in the synthesis route.

2. Selection of synthesis route and reaction design

(1) Complete the design of each step and evaluate the profile, impurity spectrum, yield, and quality of each reaction step based on previously accumulated knowledge.
(2) Complete the post-treatment design of each step, including quenching, purification, filtration, and drying.
(3) RFT (Right First Time).

3. Process optimization.

(1) Comparation of before-and-after optimization and determination of "key process points."   
(2) Draft preliminary quality standards for starting materials and intermediates.

4. Impurity spectrum study.

(1) A comprehensive study is not required.   
(2) There should be an overview of the major impurities.

5. Analysis of the reaction mechanism.

(1) Analyze the reaction mechanism of each step and find the direction of controlling side reactions.
(2) Choose the conditions that are favorable for the primary reaction.