Analytical Development and Quality Research (GMP)

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  Method development, validation and release test

  ▪ Content and related substance analysis
  ▪ Chirality
  ▪ Counter ion
  ▪ Dissolution
  ▪ Genotoxic impurity （LC-MS/GC-MS）
  ▪ Residual solvent
  ▪ Heavy metal elemental analysis
  ▪ Physicochemical(XRPD/PSD/TGA)
  ▪ Excipient release test
  

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  Stability Research

  ▪ Stability research of new active substances and medicinal products
  ▪ Stability research under long-term storage and accelerated condition
  ▪ Photostablity research
  ▪ Stability research
  -Manufacturing process change research
  -Forced degradation test/stability evaluation under accelerated condition
  

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  Impurity Related Service

  ▪ Stability-indicating method development for related substance analysis and method validation
  ▪ Impurity isolation and structure elucidation
  ▪ Impurity standard, labeled compound and metabolite’s synthesis and preparation
  ▪ Impurity standard characterization and qualification
  ▪ Synthetic route evaluation and Genotoxicity prediction
  ▪ GTIs method development, validation and sample test
  ▪ Heavy metal elemental analysis and residual solvent method development, validation and sample test
  ▪ Degradation pathway research of pharmaceutical degradants