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Trace Chemical Analysis for Genotoxic Impurities/Carcinogens

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What are Genotoxic Impurities (GTIs)

Genotoxic Impurities (GTIs) are compounds that have an established in vitro or in vivo capability to damage DNA, potentialy leading to tumor development. Compounds that are suspected to be genotoxic, for example by being structurally similar to known genotoxic impurities, are known as potential genotoxic impurities (PGTIs).1

1Looker, et al. Organic Process Research and Development, 2010, 14, 1032-1036

Genotoxic Impurities in small molecule development present risks during manufacture process. Risk evaulation and control of genotoxic impurities are needed - patient safety aligned with today's regulatory landscape. A new Multidisciplinary ICH Guideline, M7, on Genotoxic Impurities was issued June 2014.

What is Wilmington PharmaTech's Approach to Genotoxic Impurities?

WPT specializes in finding practical solutions to the complex challenges involved in genotox impurities/carcinogens trace chemical method development and analysis in complex API and formulation matrix. WPT can promptly develop robust, qualified or validated analytical methods for GTI's and PGTI's that are custom designed for your needs and suitable for use in CMC filings. Please search and inquire for your needs.

Currently, WPT is offering a genotoxic impurity assessment report FREE of charge to our customers. Please contact us for details.

Services Offered

  • GTI Method Development to ppm Level per Development Stage
  • GTI Method Qualification/Validation per Development Stage
  • Evaluation of Genotoxic/Carcinogens from Synthetic Routes
  • Control Strategy to Maximize Customer's Benefits in Balance between Risk and Cost
  • Evaluation of GTI Stability and GTI Handling Issues in Sample Matrix
  • Analytical Support for Controlling GTI in Process
  • GTI Analysis and COAs for GMP Process, Starting Materials, Intermediates and APIs
  • Integrated Approaches to Meet Our Customer Needs
Our Specialties
  • Highly-experienced Industrial Analyical Chemists in GTI Method Development/Validation/Analysis
  • State of the Art Instrumentation
  • Dedicated and Committed to All Our Valued Customers
Instrumentation on Site
  • GC-FID and GC-ECD
  • Additional Instrumentation Available Through Collaborations with University of Delaware
Example Potential Genotoxic Impurities