Process chemistry research and development

  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 microscopy
• Elemental Analysis: ICP-OES
• Identification: NMR, FT-IR
• General Testing: KF, UV-Vis, Polarimeter