Nitrosamine Risk Assessment

Key Takeaways Introduction: The Convergence of High-Risk Drug Classes and Continuous Manufacturing Nitrosamine Testing for High-Risk Drug Classes under continuous […]

Nitrosamine control during supplier qualification represents a critical intersection of regulatory compliance, quality assurance, and procurement strategy in pharmaceutical manufacturing.

Introduction: Why Nitrosamine Testing for Peptides and Oligonucleotides Matters Now Nitrosamine Testing for Peptides and Oligonucleotides has become a critical

Introduction: How API Synthesis Optimization to Reduce Nitrosamine Risk Works API Synthesis Optimization to reduce Nitrosamine Risk begins with designing

Introduction: Understanding Process Parameters in Nitrosamine Formation Nitrosamine formation in pharmaceutical products is not accidental. It is driven by well-defined

Summary — Key Takeaways Introduction: Understanding Packaging Nitrosamine Formation Packaging-related nitrosamine formation is a complex and often underestimated source of

Introduction: Understanding Excipient Impact on Nitrosamine Formation The Excipient Impact on Nitrosamine Formation has become one of the most sensitive

Pharmaceutical companies around the world are under strict watch by regulatory bodies like the FDA and EMA. This is largely

Introduction In the pharmaceutical world, keeping drugs safe from harmful impurities like nitrosamines is now more important than ever. That’s

Pharmaceutical companies worldwide are under increasing regulatory pressure to assess, mitigate, and report the risk of nitrosamine impurities in drug