What is it about?

Nitrosamine impurities are chemical compounds that have been found in some medications, raising concerns about their potential health risks. These impurities are formed unintentionally during the manufacturing process of certain drugs and can be harmful if present in high amounts.

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Why is it important?

This review's thorough examination of a quickly developing topic that has attracted a lot of attention recently from the public, pharmaceutical corporations, and regulatory bodies is what makes it very special and relevant. Commonly used drugs including ranitidine and angiotensin II receptor blockers (ARBs) include nitrosamine impurities, which have prompted many product recalls and sparked worries about possible health hazards. Therefore, a deeper comprehension of these contaminants, their underlying sources, and practical mitigation techniques are desperately needed. In-depth analysis of the most recent analytical methods for identifying and measuring nitrosamine contaminants, which is essential for guaranteeing the security and caliber of pharmaceutical items, makes this review unique.

Perspectives

I find the issue of nitrosamine contaminants in drug products both captivating and deeply concerning. These impurities highlight the complexities involved in pharmaceutical manufacturing and the vigilance required to ensure patient safety.

DARSHAN BHIRUD
School of Pharmacy & Technology Management, Shirpur, Maharashtra

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This page is a summary of: Nitrosamine Impurities in Pharmaceuticals: An Empirical Review of their Detection, Mechanisms, and Regulatory Approaches, Current Topics in Medicinal Chemistry, March 2024, Bentham Science Publishers,
DOI: 10.2174/0115680266278636240125113509.
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