In:
Applied Spectroscopy, SAGE Publications, Vol. 68, No. 4 ( 2014-04), p. 445-457
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.
Type of Medium:
Online Resource
ISSN:
0003-7028
,
1943-3530
Language:
English
Publisher:
SAGE Publications
Publication Date:
2014
detail.hit.zdb_id:
1474251-2
SSG:
11