Nitrosamine Drug Substance Related Impurities

Elemental Impurities

A special thanks to Matt Webberley, Associate Director Analytical Research and Development at our Ireland site of SK pharmteco Analytical Services, for his assistance with the profiles of AAS, ICP-OES, ICP-MS, and XRD.  A Definition of These Newsmakers Elemental impurities in food have been in the news recently, with reports of everything from lead being […]

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Nitrosamines: An Update

The linkage between nitrosamines and cancer was first postulated by William Lijinsky in 1970. Then, in 2018, N-nitroso-dimethylamine (NDMA)) was detected in an active pharmaceutical ingredient, Valsartan (an Angiotensin-II-receptor antagonist).  Finally, the FDA issued a guidance for the industry, “Control of Nitrosamine Impurities in Human Drugs”, in the fall of 2020. However, the guidelines continue to

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Nitrosamines in Food and Beverages

This is the third in a series of entries examining nitrosamines in a range of products. Our first of two previous articles presented an overview of nitrosamines, including a historical look at their implication as a probable carcinogen. In the second entry, we reviewed their presence in active pharmaceutical ingredients (APIs), and how to remove them.  Nitrosamines are organic compounds

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Nitrosamines in Active Pharmaceutical Ingredients 

This is the second in a series of entries examining nitrosamines in a range of products. Our first article presented an overview of nitrosamines, including a historical look at their implication as probable carcinogens. This entry will review their presence in active pharmaceutical ingredients (APIs) and process mitigation strategies.   Nitrosamines are organic compounds found in medications, the human

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Nitrosamines: An Overview

Nitrosamines are organic compounds found in the human diet and other environmental outlets. Being potent carcinogens that can cause tumors in nearly all organs, they have been classified as genotoxic impurities (GTIs). There are guidelines and rulings by various regulatory organizations, including the FDA, EPA, EMA, and the IARC (International Agency for Research on Cancer).

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