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Impurity Research

Wuxi AppTec analytical service laboratories provide comprehensive analytical services for impurity control, including impurity identification & characterization, structure elucidation, impurity separation, toxicity and genotoxicity evaluation, and full methodology study for different kinds of impurities.

Impurity Profile Study

  • Summarize potential impurity based on the understanding of the chemistry process
  • Analyze the impurity profile with data collection at different development stage using multiple analytical technologies
  • Design impurity control strategy based on the impurity profile study and the process scheme

Genotoxic Impurity Evaluation and Control

  • Genotoxic impurity prediction (structure based) based on ICH M7 guideline
  • Ames testing for potential genotoxic impurity (PGI)
  • Genetic toxicity testing for impurity
  • Animal toxicity study for impurity
  • Genotoxic impurity method development, validation and testing

Impurity Synthesis and Characterization

  • Synthesis of impurity reference standard, impurity marker and metabolite
  • Intended for purpose impurity characterization and testing

Extractable/Leachable

  • Extractable study, data evaluation and risk assessment
  • Leachable method development, validation and testing

Impurity Identification

  • Preliminary identification using LC-MS system
  • Impurity isolation by preparative HPLC/SFC
  • Impurity structure elucidation and impurity matching confirmation

Degradation Study

  • Forced degradation study
  • Degradant identification and degradation pathway study

Impurity Analytical Method Development, Validation and Testing

  • Stability-indicating impurity method development (through systematic column screening), validation and testing
  • Chiral method development (high throughput screening), validation and testing
  • Genotoxic impurity method development, validation and testing
  • Element impurity method development, validation and testing
  • Residual solvent method development, validation and testing
  • Screen known toxic impurity using available general methods

Bioanalytical Services

 

Toxicology Services

 

DMPK Services