Impurity Level Confirmation by Nuclear Magnetic Resonance (NMR) Spectroscopy
Two approaches for determining known process impurity levels in multiple batches of API.
This case study discusses two approaches taken when clients required determination of known process impurities in multiple API batches, addressing technical challenges in impurity detection.
This case study discusses two approaches taken when clients required determination of known process impurities in multiple API batches, addressing technical challenges in impurity detection.
Why NMR
NMR provides structural information and quantification without requiring reference standards for every impurity.
Two Approaches
Differing client needs led to complementary strategies for batch analysis.
Technical Challenges
Signal overlap and sensitivity were managed through careful method design.
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