Define and confirm key quality influencing factors of the process

Study the fate of actual impurities (greater than 0.10%) and potential impurities in the registered starting materials and separated intermediates

Collect information on registered starting materials and separated intermediates from different batch sources

Redeveloping or adjusting the analytical methods of registered starting materials and separation intermediates to ensure that the actual impurities, potential impurities and impurities generated in the subsequent reaction can be well separated

Carry out corresponding addition experiments on actual isomers, potential isomers, analogues and other by-products in the synthesis process of registered starting materials

Collect the experimental data of the study on the fate of impurities in the registered starting materials and separated intermediates, and compare them with the CQA of API to establish the control strategy for the registered starting materials and separated intermediates

Write quality standard report (record the process research and analysis research data of registered starting materials and intermediates in detail)