Quality Study, Validation, Analysis and Test

SCCIP worked with Guangdong Institute for Drug Quality to jointly set up “Drug Quality Study and Validation Platform of SCCIP” and “Experimental Base of Guangdong Institute for Drug Quality” to provide study and analysis relating to drug (medicine and preparation) criteria. The platform has attracted a number of eligible technicians and engineers and a series of instruments and devices to provide high efficient services so as to perform R&D in smooth way. 

Study on drug quality criteria

• Assessment: by chemical method, spectrophotometry (UV, IR), chromatography (TIC, HPLC, GC) to check if the drug is genuine.
 
• Inspection: general impurity, special impurity, in addition, preparative LC is used to purify the drug by separation of impurity therefrom.
 
• Determination of content: by volumetric methods, spectrometric analysis and chromatographic analysis to evaluate the drug quality.
 
• Stability trial: experiments on impacting factors, accelerated test, and chronic toxicity test.
 

Experiments on analysis and determination

• Development, optimization and verification of analytical methods: development of analytical methods, optimization of analytical conditions, and verification of methodology for crude medicine and preparation;
 
• Structure confirmation of compounds: by technology of IR, MS, NMR and for forth;
 
• Separation with chromatography: by HPLC, GC, HSCCC to separate compounds;
 

List of major apparatus in SCCIP

Service application form (linking with service application of secondary column)