APIs and Intermediates

Process Development

By consulting a large number of documents, comprehensively considering factors such as cost, production equipment, three wastes treatment, production efficiency and intellectual property protection, we provide services such as route design, screening, process parameter optimization, and process verification.
• Route design and screening
•Optimized solution design
• Process parameter optimization
• Technology transfer and process validation
•Routing design, screening
• Process safety assessment
• Scale up production

Production Process Optimization

Fully consider the customer's software and hardware conditions, create a suitable process route for the customer, and enhance the market competitiveness of the product.
• Establish central control standards
• Process parameter optimization
• Post-processing optimization
• Optimization of purification method
• Study of impurity spectrum
• CTD file authoring

Impurity Traceability & Control Research

Systematic, scientific and effective research on related substances, solvent residues, element impurities, etc. involved in the process route is the service we have been striving to provide.
• Impurity/standard preparation and standardization
•Standard preparation and standardization of APIs and intermediates
• Study of impurities and impurity spectrum
• Genotoxic impurity assessment

Clinical Sample Production

Effective process transfer can provide customers with clinical I, II, III clinical batch raw material production services, and ensure the efficient delivery of samples.
•Small trial batch production
• Safety assessment batch production
• Pilot batch production
•Clinical batch production
• GMP production of APIs