中文 English FOllOW US: logo

Early-Phase Analytical Development


Early-Phase Analytical Development

FacebookTwitterLinkedInEmail

API Method Development & Validation

  • Stability-indicating assay and impurities method using column screening technology
  • Chiral method development using column screening technology
  • Residual solvent analysis by GC or GC-HS
  • Water content analysis by KF
  • Mutagen/structure alert/PGI by LC-MS, LC-MS/MS and GC-MS
  • Counter-ion method development by titration/IC etc.
  • Trace metals (Pd, Cs, etc. ) by ICP-OES/ICP-MS
  • NMR – quantitative assay or ID test

Drug Product Method Development & Validation

  • Potency and related substance method; content uniformity/blend uniformity
  • Dissolution method for formulation screening or QC release
  • Method development for products containing multiple APIs and assisted by impurity identification by LC-MS-MS/NMR

GMP Release of API/Drug Product

GLP Release of API

Structure Elucidation

  • LC-TOF-MS, LC-MS/MS and NMR as standard technique platform
  • Sample enrichment by separation and structure verification using pure standards

Confirmation of Structure (COS)

  • NMR, accurate MS, IR, UV, elemental analysis, optical rotation etc.

Reference Standard

  • Full characterization with chromatographic purity, assay, ROI, LOD, water by KF, residual solvents, ID by NMR/IR etc.

Excipient Release

  • ID by IR or full release as per USP/EP/ChP

Case

Elemental Impurities by ICP-MS

E-Phase6