Senior Physical Organic Chemist in Pharmaceutical Stability and Stress Testing (Forced Degradation) with more than 25 years of experience in the CMC sector.

Dan did his undergraduate (BS Chemistry) and graduate (MA & PhD in Organic Chemistry) studies at the University of Texas, Austin.

Dan’s primary expertise is in elucidation of pharmaceutical degradation pathways of drug substances and formulated products, methods development, impurity isolation, impurity synthesis, drug substance purification, automated preparative chromatography, degradation studies, regulatory and technical document writing, kinetics, stability problem troubleshooting, and prediction of degradation pathways and genotox screening.

He is a leading author for guidance on degradation studies and has written several internal (GSK Chemicus) and external scientific articles for American Pharmaceutical Review, volume 153 of the series Drugs and Pharmaceutical Sciences, World Pharmaceutical Frontiers, and Tablets & Capsules.

He is known for his presentations of “Degradation Chemistry in Regulatory Submissions”, “Regulatory Guidance and Best Practices for Conducting Forced Degradation Studies” and “An Experimental Approach for Conducting Forced Degradation Studies” presented at AAPS, IIR conference on Forced Degradation and Informa Science’s second annual conference on Forced Degradation Studies conference.

His areas of expertise include:

  • Chemistry Drug decomposition/stability, analytical methods development, isolations, preparative chromatography, reaction mechanisms, photolysis, oxidation, resolution of racemic modifications, organic synthesis, kinetics.
  • Chromatography: HPLC (analytical and preparative), SFC, GC, column, flash, ion exchange, thin and thick layer, densitometry, GPC, SPE, chiral
  • Analytical : IR, GC/MS, LC/MS, PDA, polarimetry, UV, peak purity,1H and 13C NMR(2D)