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Industrial Area

Organic and mutagenic impurities

When an impurity in a medication reaches or exceeds the qualification level, the manufacturer must justify the toxicity of the impurity in accordance to the established regulations for organic impurities ICH Q3A/Q3B and mutagenic impurities ICH M7.
To justify organic and mutagenic impurities, it is necessary to identify the impurity and analyze it in order to subsequently assess the risk it may involve for human health.

At Azierta, we offer a comprehensive service covering everything from the structural elucidation of impurities to toxicological evaluation and characterisation. To do this, we use a specialised process:

Impurezas organicas y mutagenicas

Our services in toxicity of organic and mutagenic impurities

Estudios preclínicos y de seguridad

Pre-clinical studies and safety studies

  • In vivo testing
  • In vitro testing
  • Mutagenicity
  • Carcinogenicity
  • Reproductive toxicity
  • Pharmacokinetics

Análisis cuali-cuantitativo

Qualitative-quantitative analysis

  • Isolation of the impurity
  • Chromatographic techniques
  • Crystallographic Techniques
  • Impurity identification
  • Exact mass
  • Molecular formula
  • Chemical structure
  • Enantiomeric resolution
Informes toxicológicos

Toxicological report

  • Toxicological evaluation
  • Preclinical data
  • Clinical data
  • In silico tools: QSAR and Read Across
  • Drug metabolism review
  • Characterisation of the risk
  • Control strategies

We have a specialised toxicological support department composed by of a multi-disciplinary team of expert toxicologists accredited by AETOX, EUROTOX and ERT.

Leading innovation in pharma & health

100 professionals

Over 100 professionals

500 clients

Over 500 clients

9 year experience

9 years of experience


Leading innovation

Client oriented

100% client oriented

We are at your complete disposal for any inquiry

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