Consistency evaluation service
- time:2020-03-03
- browse:2076second
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
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