From Risk To Resolution: A Breakthrough in Nitrosamine Analysis & Mitigation

Since the release of the FDA’s guidance on Nitrosamine Drug Substance-Related Impurities (NDSRIs), the pharmaceutical industry has been diligently attempting to identify at-risk APIs, update risk assessments, and devise control strategies for both commercial and in-development products. However, the lack of a clear-cut definition of APIs susceptible to nitrosation has hampered these efforts. Various papers, software tools, and expert opinions have been generated, but none have provided the definitive solution needed by the industry. Adare’s framework fills this critical gap by offering a clear and actionable standard.

This framework not only streamlines the identification process but also enhances the overall safety and compliance within the industry. By adopting Adare’s approach, pharmaceutical companies can now more accurately identify at-risk APIs, implement effective control measures, and ensure the safety of their products.

For a deeper dive into this groundbreaking framework, the full article is available for download here.