A New Framework for Identifying Nitrosamine Risks and Efficiently Derisking Products

A clear standard for identifying APIs susceptible to NDSRI formation has remained elusive – until now. Adare’s team of nitrosamine experts have developed a straightforward framework that simplifies the identification of at-risk APIs.

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. But despite the numerous papers, software tools, and expert opinions generated from these efforts, there is no clear-cut definition of APIs susceptible to nitrosiation.

Best Practices • Guidances • Methods • Regulations • Regulatory • Testing