Potential genotoxic impurity

{
  "id": "MLC-T-CHM-009316",
  "term": "Potential genotoxic impurity",
  "field": "Chemistry",
  "definition": "A substance present in a drug product or its synthesis that has the capacity to damage genetic material, potentially leading to mutations or cancer. These impurities are typically present at very low levels but require stringent control due to their inherent hazard. Regulatory guidelines, such as those from the International Council for Harmonisation (ICH), set limits for their presence.",
  "subject": "Chemistry and Human Health",
  "references": [
    "PAC, 2013, 85, 1725. 'Glossary of terms used in medicinal chemistry. Part II (IUPAC Recommendations 2013)' on page 1748 (https://doi.org/10.1351/PAC-REC-12-11-23)"
  ],
  "url": "https://mlchart.com/terminology/chemistry/potential-genotoxic-impurity/"
}