Shanghai Medicilon Inc.

  Medicilon has been offering high quality analytical testing services to the pharmaceutical industry for decades. We offer a wide range of quality control testing services to support drug research, registration and production. Biopharmaceutical companies also use many of the same services and Medicilon has also added new services to accommodate their unique needs (detailed in the following section). We perform a variety of tests that are client-specific, particularly in the area of  analytical chemistry . Please inquire for more information about additional tests we perform that may not be listed in this brochure. Laboratory Services GLP and GCP  Bioanalytical Services  & Biomarkers GMP and CMC Laboratory Services Pharmaceutical Analysis, Stability and  Formulation Development  Extractables/Leachables Packaging Support Process Development and Manufacturing Analysis Support Bioanalytical Services Our teams are adept in method development,method validati...

  Process Analytical Science Our process analytical sciences group provides support for research, development and commercial production. At Medicilon, the importance of analytical support in pharmaceutical development and manufacturing is well understood.  We provide our clients with analytical method development and all other services required to support their regulatory needs. Services Offered Analytical Method Development, Qualification and Validation For Assay Related Compounds Water Content Chiral Analysis Residual Solvents Trace Metals Analysis IPC and Release Testing Impurity  Isolation and Structure Elucidation Reference Standard Qualification Stability Studies PGI Method Development, Validation and Testing Specification and Other Regulatory Filing Documentation Preparation We have the following key instrumentation to support our analytical activities Chromatography: UPLC, HPLC, LC-MS, GC, GC-HS Solid State Characterization: DSC, TGA, XRPD, PSD, Polarized Light Mi...