Genotoxic Impurities From Pharmaceutical Drugs – A Review

Authors

  • Sreelatha Gangu Assistant Professor, Department of Pharmaceutical Analysis, CMR College of Pharmacy, Kandlakoya, Medchal, Hyderabad, Telangana, India – 501 401.
  • Varada Bala Gnana Laxmi CMR College of Pharmacy, Kandlakoya, Medchal, Hyderabad, Telangana, India.
  • Sitawar Anusha CMR College of Pharmacy, Kandlakoya, Medchal, Hyderabad, Telangana, India.
  • Akshay Rathod CMR College of Pharmacy, Kandlakoya, Medchal, Hyderabad, Telangana, India.
  • Rama Rao Tadikonda CMR College of Pharmacy, Kandlakoya, Medchal, Hyderabad, Telangana, India.
  • Narender Boggula CMR College of Pharmacy, Kandlakoya, Medchal, Hyderabad, Telangana, India.

Abstract

Genotoxic impurities are the substances that can potentially damage to an organism’s genetic material that may lead to mutations. Genotoxic impurities (GTIs) in pharmaceuticals at trace levels are of increasing concerns to both pharmaceutical industries and regulatory agencies due to their potentials for human carcinogenesis. The impurities formed may be intermediate, through are material, chemical reaction, as by products due to catalyst excipients or in storage. They are unavoidable hence they are kept under threshold limit. The criteria for these genotoxic impurities are mentioned. As per ICH M7 Guidelines acceptable daily exposure is 5.0 mg/ml/day. Other guidelines like EMA, USFDA provide specific guidelines for these genotoxic impurities. Some of these impurities are detected and the methods of the detections include HPLC, GC, and ion chromatography. The genotoxic impurities are classified as organic impurities and inorganic impurities.

Published

2024-05-01