Toxicological Services

Intrinsik’s experienced team include board certified toxicologists to provide expert assessments and advice.


Impurities, and Extractables and Leachables Toxicological Risk Assessments

  • Surrogate Justification and Selection for Extractable & Leachable Compounds Lacking Toxicity Data
  • Evaluation of Extractable & Leachable Toxicity at Functional Group Level
  • Evaluation of impurities in the API and/or drug product consistent with ICH M7 recommended approaches for initial assessment of impurities, using an FDA-validated software program that includes both expert rule- and statistical-based models
  • Identification of structural alerts in pharmaceutical compounds and impurities using QSAR
  • Evaluation of extractable/leachable impurities and justification for the safety of extractables in the API and drug product
  • Support for Toxicity Testing of Impurities
  • Impurity Purge Evaluation


  • Evaluation of excipients that exceed FDA inactive ingredient levels and development of higher safe levels acceptable to the agency
  • Excipient Qualification Involving Permissible Daily Exposure (PDE), Tolerable Intake (TI), Acceptable Intake (AI), and Threshold of Toxicological Concern (TTC) Derivations
  • Specification Limit and Toxicological Justification

 Nitrosamine and Nitrosamine Drug Substance Related Impurities (NDSRIs)

  • Nitrosamine Risk Assessment
  • Assistance with Carcinogenic Potency Categorization Approach (CPCA) for NDSRIs
  • Alternative AI Derivation for NDSRIs using Robust Surrogate Data
  • QSAR Support for Alternate NDSRI Surrogate Selection
  • Support for Nitrosamine-Specific In Vitro and In Vivo Genotoxicity Testing

Pharmaceutical Environmental Health and Safety

  • Occupational Health Characterization (OHC), Occupational Exposure Limit (OEL) Derivation and Occupational Exposure Banding (OEB)
  • Manufacturing Cleaning Validation
  • Childproof Packaging F-value Calculation
  • Safety Data Sheets
  • Ecological Risk Assessment

How Can We Help?

Our scientists have the expertise to address your complex
toxicological health and environmental issues, including product
development and business risks to avoid scientific and regulatory delays.

Contact Us