Nitrosamines & Genotoxic Impurities in Pharmaceutical Development and Manufacturing

Nitrosamines have become one of the defining challenges in pharmaceutical analysis, and this eBook from LCGC International captures the field at a pivotal moment. Inside, a roundtable of leading voices examines a discipline progressing rapidly, yet still grappling with analytical, toxicological, and regulatory uncertainties, a survey maps the latest chromatographic and risk-modeling research, and a featured study reveals how NDSRIs can even form after a drug is swallowed, under simulated gastric conditions. Add in a practical guide to formation pathways and mitigation strategies, and you get a comprehensive look at where nitrosamine detection, regulation, and risk management stand today. Whether you're developing methods for trace-level impurity detection or want to understand where the regulatory and scientific landscape is headed, this eBook delivers the research and expert insight to keep you ahead of a genuinely moving target.