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Application of Mid-Infrared Spectroscopy to the Development and Transfer of a Manufacturing Process for an Active Pharmaceutical Ingredient

Volume 66, Number 5 (May 2012) Page 574-579

IAN M. CLEGG,* ADRIAN M. DALY, CRAIG DONNELLY, RUTH HARDY, DENISE HARRIS, HAYLEY JACKMAN,* RICKY JONES, AMY LUAN, DOUGLAS MCANDREW, PAT MCGAULEY, JOHN PEARCE, GEMMA SCOTNEY, and MAY-LING YEOW


The use of in situ mid-infrared spectroscopy to support the development of a pharmaceutical manufacturing process is disclosed. Data on this two-stage telescoped reaction from several reaction scales (<50 mL to 1600 liters) and at multiple manufacturing locations is shown. In addition to providing data on both reactions in the telescope, the mid-IR data has been used to monitor an intermediate distillation operation and therefore it has been possible to profile the whole process. Data is also shown on aliquot addition during the first chemical transformation, which is used to check the instrumentation.



Index Headings: Process analytical technology; PAT; Mid-infrared spectroscopy; Process development; Crizotinib.