Consistency evaluation service

time:2020-03-03 browse:2723second

The company provides the following consistency evaluation services to our customers:

一、comprehensive comparison of the quality of reference preparations and generic drugs:

Determine the determination conditions of the four dissolution curves, determine the dissolution curves of the reference preparation and the imitation preparation, and compare the dissolution curves;

Determining related substances, isomers, etc., and determining related substances, contents, isomers, etc. of reference preparations and imitation preparations;

Study on the crystal form of the drug substance used in reference preparations and generic preparations;

Stability studies (including influencing factors, acceleration and long-term);

二、Second development service of prescription technology:

Need to study the quality of the original agent more deeply;

Fully study the properties of the drug substance;

Adjust and optimize the prescription and process, and ensure the durability of the prescription process by stepwise amplification;

Pilot scale-up / production technology transfer;

Quality Research