MITIGATING N-NITROSAMINE IMPURITIES IN PHARMACEUTICALS: DETECTION, RISK AND REGULATORY MEASURES
Yogeshwari M. Kadam*, Hemant P. Alhat, Sarika H. Alhat and Shashikant N. Dhole
ABSTRACT
A nitrosamine impurity partially nitrosamine derived from secondary amine, posses significant risk due to their established carcinogenic properties. These organic compound health garnered attention, particularly after their detection in various medication, including angiotensine II receptors blockers and anti-diabetic drugs, prompting recalls and regulatory scrutiny. The formation of nitrosamines is attributed to reactions involving amides, carbamates, and nitrites during pharmaceutical manufacturing processes. Advance analytical techniques such as HPLC-HRMS and GCMS are crucial for detecting these impurities, ensuring that their levels remain complaint with safety standards set by regulatory agencies like the FDA, ICH and USP. To mitigate risks, comprehensive guidelines have been established, focusing on rigorous risk assessments and the need for stringent controls over raw materials and manufacturing processes. Ongoing research and cooperation between regulatory authorities and the pharmaceutical sector are crucial for maintaining the safety and effectiveness of medicinal products.
Keywords: Nitrosamines, Impurities, Advance analytical methods, Regulatory guidelines.
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