David Elder
Papers
1
Total Citations
36
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1
About
David Elder is a distinguished pharmaceutical scientist whose research focuses on analytical chemistry, genotoxic impurity control, and pharmaceutical quality assurance. His most impactful work centers on the development and validation of advanced analytical methods for detecting and quantifying potentially carcinogenic impurities in drug substances. Elder's landmark 2008 study, which introduced an automated static headspace gas chromatography–mass spectrometry (SHS-GC–MS) method for monitoring ethyl methane sulfonate formation from ethanol and methane sulfonic acid, has garnered 36 citations and remains a foundational reference in genotoxic impurity analysis. This work directly addressed critical safety concerns in pharmaceutical manufacturing, enabling more reliable risk assessment and regulatory compliance. Through his rigorous method development and validation strategies, Elder has significantly advanced the field's understanding of impurity formation pathways and analytical detection limits. His contributions have been instrumental in shaping current regulatory guidelines for genotoxic impurities, making him a respected authority in pharmaceutical analytical chemistry and quality control.
Research Focus
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