Nitrosamine Impurities in Pharmaceutical Products: A Comprehensive Review of Sources, Analytical Detection Methods, Toxicological Risks, and Regulatory Guidelines

Nitrosamine Impurities in Pharmaceuticals: Sources, Detection, Risks, and Regulations

Authors

  • Krishna Deore Department of Pharmaceutics, Y. B. Chavan College of Pharmacy, Aurangabad, Maharashtra India, 431003
  • Mr. Ismail Mouzam Department of Pharmaceutics, Y. B. Chavan College of Pharmacy, Aurangabad, Maharashtra India, 431003

DOI:

https://doi.org/10.61920/3x6f8b82

Keywords:

Nitrosamine impurities, Pharmaceutical Contamination, Detection Techniques, Health Risks, Regulatory Guidelines

Abstract

Nitrosamine impurities pose a significant health risk in pharmaceutical products due to their carcinogenic, mutagenic, and DNA-damaging properties. These organic compounds can form from various sources such as raw materials, intermediates, solvents, and packaging materials used in the manufacturing and storage of active pharmaceutical ingredients (APIs) and finished drug products. Contamination has been identified in drugs like ranitidine, nizatidine, metformin, and certain angiotensin II receptor blockers (ARBs). This review provides a comprehensive overview of the chemistry, sources, formation mechanisms, and environmental influences contributing to nitrosamine formation. It also discusses key analytical techniques for detection and quantification across APIs, excipients, and packaging components. Additionally, current global regulatory frameworks from the EMA, FDA, and USP are summarized, offering insights into permissible limits and compliance strategies. The article further explores challenges and preventive measures to control nitrosamine contamination, guiding pharmaceutical industries in quality assurance and risk management practices.

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Published

2025-07-13

How to Cite

Nitrosamine Impurities in Pharmaceutical Products: A Comprehensive Review of Sources, Analytical Detection Methods, Toxicological Risks, and Regulatory Guidelines: Nitrosamine Impurities in Pharmaceuticals: Sources, Detection, Risks, and Regulations. (2025). Journal of Drug Delivery and Biotherapeutics, 2(3), 23-42. https://doi.org/10.61920/3x6f8b82