APIs Development & Registration Services
· Synthesis route development & optimization
· Pilot transfer and process scale-up
· Process verification method development
· Stability testing
· Documentation preparation and submission
· Complementary research
Formulation Development
· Reference formulation analysis
· Laboratory-scale, pilot-scale, and validation of prescription studies
· Stability testing
· Documentation preparation and submission
· Complementary research
Impurities & Working Standards
Customization Services
· Chiral impurities
· Impurities for registration use
· New drug impurities
Testing Services
· Genotoxic impurity research
· Elemental impurity research
· Packaging material compatibility research
· Sealing ability research
· Basic testing
Analytical Method Development
Elemental Impurity Research and Testing
· Semi-quantitative scanning of elemental impurities
· Qualitative and quantitative detection of elemental impurities (ppt to ppm level)
· Research on routine 7 elements in oral drugs
· Research on routine 10 elements in injectable drugs
· Method development and sample testing
· Comprehensive elemental impurity risk assessment
Residual Solvent Research and Testing
· Residual solvent research for raw materials, formulations, starting materials, and excipients
· Identification of unknown solvent peaks
Impurity Research and Testing
· Impurity source analysis
· Process impurity & degradation impurity research
· Genotoxic impurity research
· Nitrosamine impurity research
· Polymer impurity research
Stability Research and Testing
· Influence factor testing
· Accelerated testing
· Long-term testing
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