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 »
🔍 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: Direct Injection vs. Headspace Techniques for Nitrosamine Volatiles in APIs When discussing Direct Injection vs. Headspace Techniques for
Direct Injection vs. Headspace Techniques for Nitrosamine Volatiles in APIs 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 »
Introduction Pharmaceutical quality standards continue to rise, requiring analytical techniques that can detect impurities at extremely low levels. HRMS for
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 »
