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Optica Publishing Group
  • Applied Spectroscopy
  • Vol. 68,
  • Issue 4,
  • pp. 445-457
  • (2014)

On-Line Application of Near-Infrared Spectroscopy for Monitoring Water Levels in Parts per Million in a Manufacturing-Scale Distillation Process

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Abstract

An on-line analytical method based on transmission near-infrared spectroscopy (NIRS) for the quantitative determination of water concentrations (in parts per million) was developed and applied to the manufacture of a pharmaceutical intermediate. Calibration models for water analysis, built at the development site and applied at the manufacturing site, were successfully demonstrated during six manufacturing runs at a 250-gallon scale. The water measurements will be used as a forward-processing control point following distillation of a toluene product solution prior to use in a Grignard reaction. The most significant impact of using this NIRS-based process analytical technology (PAT) to replace off-line measurements is the significant reduction in the risk of operator exposure through the elimination of sampling of a severely lachrymatory and mutagenic compound. The work described in this report illustrates the development effort from proof-of-concept phase to manufacturing implementation.

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