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 (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 »
🔍 Summary: Key Insights Introduction: Why the Nitrosamine CPCA Approach for NDSRIs Matters The Nitrosamine CPCA approach for NDSRIs (Carcinogenic
Implementing the Carcinogenic Potency Categorization Approach (CPCA) for NDSRIs Read More »
Introduction Isomeric Nitrosamines Analysis is considered one of the most demanding areas in pharmaceutical quality control and environmental testing. These
Solving Chromatographic Challenges for Isomeric Nitrosamines Read More »
Introduction Achieving Ultra-Low Limit of Quantitation (LOQ) in Nitrosamine Testing requires a well-coordinated combination of analytical precision, instrument optimization, and
Strategies for Achieving Ultra-Low Limit of Quantitation (LOQ) in Nitrosamine Analysis Read More »
🧪 Introduction: Why Sample Preparation Strategies for Nitrosamine Testing Are Essential Effective Sample Preparation Strategies for Nitrosamine Testing are the
Comprehensive Sample Preparation Strategies for NDSRIs in Complex Drug Products Read More »
Summary Introduction: GC-MS Method Development for Nitrosamine Testing GC-MS Method Development for Nitrosamine Testing is critical for protecting patient safety,
Advanced GC-MS/MS Method Development for Volatile Nitrosamines (e.g., NDMA, NDEA) Read More »
