Our professional analytical research and development, and QC teams provide comprehensive support to process development and manufacturing. Our experienced analytical chemists use a range of modern analytical instruments and can respond quickly to client needs and provide high level analytical services.
Analytical capabilities include:
Analytical method development and method validation.
Establish accurate and efficient analytical methods to meet the needs of the different stages of drug development. The use of UHPLC and SFC screening systems aid in the rapid establishment of analytical methods, including for detection of impurities, potency assays and chiral purity. Use of forced degradation in the development of SIMs.
Reference standard characterization.
Impurity identification and characterization.
Impurity identification using NMR (1H NMR、13C NMR、19F NMR, and 2D NMR) MS (LCMS, HRMS, GCMS), IR, UV and so on.
Elemental impurity tests.
Ability to detect and quantitate 66 elemental impurities using ICP-MS.
Other analytical techniques.
Water content (KF titration), residual solvents (HSGC), PSD, XRPD, TGA , DSC, melting point and so on.
Analytical method transfer.
Well-designed procedure to ensure efficient transfer and qualification of analytical methods.
Release testing for raw materials, packaging materials and intermediates.
Release testing for final products.
Stability study.
Stress testing, forced degradation, and accelerated and long-term stability studies using ICH stability chambers.
Please feel free to contact us if you have any questions.