Introduction In active pharmaceutical ingredient (API) manufacturing, Nitrosamine Solvent Catalyst Mitigation has become one of the most important topics for […]
Mitigating Nitrosamine Formation from Solvents and Catalysts in API Manufacturing Read More »
Introduction: The Role of Secondary Amine Scavenger Nitrosamine in Drug Product Stability The use of Secondary Amine Scavenger Nitrosamine control
Secondary Amine Scavenging Strategies and the Impact on Drug Product Stability Read More »
Summary Introduction: Why Advanced Nitrosamine Purge Factor Calculation Is the Regulatory Game-Changer In today’s pharmaceutical impurity control landscape, Nitrosamine Purge
Advanced Purge Calculation Methodologies and Regulatory Acceptance Read More »
Summary (Key Takeaways) Introduction: The Overlooked Role of Excipients in Nitrosamine Risk For many years, the pharmaceutical industry focused mainly
Identifying and Controlling Excipient Contamination as a Nitrosamine Source Read More »
🔍 Summary (Quick Insights) Introduction A robust NDSRI Risk Assessment Methodology is now a core element of modern pharmaceutical impurity
Deep Dive: Risk Assessment for Nitrosamine Drug Substance-Related Impurities (NDSRIs) Read More »
Summary (Key Takeaways) Introduction: Defining Nitrosamine Specification Setting in the Pharmaceutical Context Nitrosamine Specification Setting refers to the systematic process
Establishing Specifications for Nitrosamines in Drug Substances and Drug Products Read More »
Introduction: The Nexus Between Nitrosamine AI Limit and CPCA Category The connection between the Nitrosamine AI limit and CPCA category
The Role of Acceptable Intake (AI) Limit Derivation and CPCA Category Assignment Read More »
Introduction Less-Than-Lifetime (LTL) Exposure Calculations for Nitrosamines are a critical toxicological tool used when patient exposure to nitrosamine impurities occurs
Less-Than-Lifetime (LTL) Exposure Calculations for Nitrosamines: When and How to Apply Read More »
🔹 Executive Summary Introduction: Understanding the Nitrosamine AI Limits Comparison When conducting a Nitrosamine AI limits Comparison across major regulatory
Global Regulatory Divergence: FDA vs. EMA vs. Health Canada on AI Limits Read More »
Introduction: Understanding the Impact of ICH M7(R2) Updates on Nitrosamine Risk Assessment The Impact of ICH M7(R2) Updates on Nitrosamine
The Impact of ICH M7(R2) Updates on Nitrosamine Risk Assessment and Control Read More »
