Genotoxic Impurity Test

Genotoxic Impurity Test

Protheragen-ING Lab offers comprehensive pharmaceutical genotoxic impurity test services to ensure the safety and quality of pharmaceutical products. Genotoxic impurities are substances that have the potential to cause genetic toxicity, including mutagenic impurities and other types of non-mutagenic impurities. These impurities can pose a significant risk to human health, potentially leading to DNA damage, mutations, and even carcinogenic effects. Our state-of-the-art testing methodologies and expertise enable us to accurately detect and quantify genotoxic impurities, ensuring compliance with regulatory guidelines and safeguarding public health.

Fig.1 Some examples of genotoxic compounds in drug substances.Fig 1. Genotoxic compounds in drug substances[1].

Comprehensive services of Protheragen-ING Lab

We perform genetic impurity testing according to ICH M7 (Mutagenic Impurity Evaluation and Control). We possess the necessary expertise and cutting-edge equipment to support the entire process of genotoxic impurity research. Our comprehensive range of instruments includes GC-MS, GC-MS/MS, LC-MS/MS, Spectrometry Q-Exactive (LC-HRMSMS), Ion Chromatography (IC), and CAD, enabling us to develop and validate genotoxic impurity analysis methods.

Impurity Spectrum Analysis and Structural Confirmation:

We utilize process understanding and impurity profiling to analyze impurity spectra, combining them with high-resolution mass spectrometry to achieve precise qualitative and confirmatory analysis of trace impurity structures.

QSAR Toxicity Prediction:

Our services feature CASE Ultra, a genotoxicity prediction system based on statistical principles and expert knowledge rules that fully comply with the ICH M7 guidelines. It enables accurate prediction of genotoxic potential for various compounds.

Method Development and Validation:

Following the ICH M7 guidelines, we develop and validate analytical methods for the determination of genotoxic impurities in pharmaceuticals. We calculate the limits of genotoxic impurities based on regulatory requirements.

Scope of Services:

  • Testing of New Active Pharmaceutical Ingredients (APIs) and Formulations - We provide genotoxic impurity testing services for new APIs and formulations during the research and development phase as well as the regulatory submission phase.
  • Post-Approval Testing for Marketed Drugs - Our services also cover the analysis of genotoxic impurities in approved marketed drugs. This includes new market applications for formulations produced from the same API.
  • Analysis of Synthetic Excipients -dd We offer testing services for genotoxic impurities present in chemically synthesized excipients used in pharmaceutical formulations for the first time.

Our expertise

With years of experience in genotoxic impurity analysis, we have developed hundreds of analytical methods for the detection and quantification of various genotoxic impurities, including:

a. Nitrosamines

b. Alkyl/Aryl Sulfonates

c. Halogenated Alkanes

d. Halogenated Acids

e. Acyl Halides

f. Epoxides

g. Sulfates

h. Phosphates

i. Carbamates

j. Azides

k. Nitrites

l. Diazo Compounds

m. Hydrazines

n. Aromatic Amines

o. Formaldehyde/Acetaldehyde

p. Aminoglycoside Antibiotics

ICH M7 genotoxic impurity classification

  • Known Mutagens with Known Carcinogenic Potential
  • Known Mutagens with Unknown Carcinogenic Potential
  • Alerting Structures (Unrelated to API Structure) with Unknown Mutagenic Potential
  • Alerting Structures (Related to API Structure) Tested and Found Non-Mutagenic
  • No Alerting Structures or Alerting Structures with Data Demonstrating Non-Mutagenicity and Non-Carcinogenicity

We are committed to assisting pharmaceutical companies in ensuring the safety and efficacy of their products, ultimately safeguarding the well-being of patients worldwide. Contact us today to discuss your specific testing requirements and benefit from our comprehensive genotoxic impurity testing services.


  1. Gosar A, et al. (2014). "Genotoxic Impurities and Its Risk Assessment in Drug Compounds." Drug Designing & Intellectual Properties International Journal.