Genotoxic Impurity Risk Assessment
Genotoxic impurities (GTIs) refer to a class of impurities that, even at low levels, can directly cause DNA damage, lead to DNA mutations, and are carcinogenic or potentially carcinogenic. During drug development and manufacturing, genotoxic impurities may originate from starting materials, reactants, catalysts, solvents, intermediates, by-products, or degradation products. Due to the significant risk they pose to drug safety and patient health, regulatory authorities worldwide impose stringent requirements for the assessment and control of genotoxic impurities.
Protheragen Impurity is committed to providing comprehensive genotoxic impurity risk assessment solutions to global pharmaceutical companies and research institutions. We have a core team of experienced medicinal chemists, analytical chemists, toxicologists, and regulatory experts who are equipped to address complex challenges, ensuring the effective identification, assessment, and control of genotoxic impurities in drugs, ultimately safeguarding patient safety. If you are looking for a reliable partner, please feel free to contact us.
Our Services
Protheragen Impurity offers one-stop genotoxic impurity risk assessment services covering the entire drug development process, ensuring your project receives professional support at every stage. Based on the drug's process route and bill of materials, we provide research services including potential impurity identification and categorization, toxicological data queries, genetic toxicology testing, and risk assessment report preparation.
Synthetic Route Evaluation & Genotoxic Impurity Screening
(Q)SAR Computational Toxicology Assessment
In Vitro Chromosome Aberration Test
In Vivo Micronucleus Test
In Vivo Chromosome Aberration Test
Database and Literature Search-based Assessment
Ames Test
In Vitro Micronucleus Test
In Vivo Alkaline Comet Assay
Analytical Method Development and Validation
Our Technology
High-performance liquid chromatography (HPLC)
Liquid chromatography-mass spectrometry (LC-MS)
Inductively coupled plasma mass spectrometry (ICP-MS)
Inductively coupled plasma optical emission spectroscopy (ICP-OES)
(Q)SAR software
Gas chromatography-mass spectrometry (GC-MS)
Nuclear magnetic resonance (NMR) spectroscopy
Ultra-high performance liquid chromatography (UPLC)
Ion chromatography (IC)
Others
Deliverables
Process route assessment report
Genotoxic impurity detection report
Comprehensive risk assessment report
(Q)SAR prediction report
GLP genotoxicity study report
Other data
Process of Our Services
Why Choose Us?
01
Expert Team
Our core team members each possess over 5 years of industry experience and have handled numerous complex cases. From prediction and analysis to in vivo and in vitro testing, we provide seamless end-to-end services.
02
Cutting-Edge Analysis Platform
We are equipped with a variety of high-sensitivity analytical instruments and advanced prediction software, ensuring the sensitivity and accuracy of impurity detection, delivering reliable data for risk assessment.
03
Customized Services
We understand that every project is unique. We offer highly flexible and tailored service solutions, adapting to your project stage and budget to provide the most cost-effective services.
04
Stringent Quality Management System
All our processes adhere to a strict quality management system, ensuring authentic, accurate, and traceable data. This has earned us an outstanding reputation among clients worldwide.