Discover how advanced NMR reveals and quantifies a trace impurity in drug development in this case study.
How can NMR spectroscopy unlock clarity in genotoxic impurity analysis?
Discover how advanced NMR techniques enabled structural confirmation and quantification of a trace-level impurity in a complex drug product.
Genotoxic impurities pose serious risks in pharmaceutical development, demanding precise identification and control. In this case study, our experts leveraged Nuclear Magnetic Resonance (NMR) spectroscopy to overcome analytical challenges where traditional methods fell short. From isolating a suspected impurity to confirming its structure and quantifying it without a reference standard, NMR proved indispensable – delivering regulatory-compliant data and enabling routine monitoring.
Explore how NMR can elevate your impurity profiling strategy and support your regulatory submissions with confidence.
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Genotoxic Impurities and Mutagenic Impurities Analysis
Genotoxic impurities analysis to assess and control DNA reactive mutagenic impurities in pharmaceuticals
Switzerland Analytical Laboratory
Intertek's Swiss analytical laboratory provides advanced lab testing to GLP/GMP standards for the pharmaceutical and medical device sectors