title: Application of mid-infrared spectroscopy to the development and transfer of a manufacturing process for an active pharmaceutical ingredient.
abstract: 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.
authors.affiliation: Analytical Development, PTx Pharmaceutical Sciences, Pfizer World Wide Research and Development, Sandwich Laboratories, Sandwich, Kent, CT13 9NJ, UK. ian.clegg@novartis.com
authors.forename: Ian M
authors.initials: IM
authors.lastname: Clegg
authors.forename: Adrian M
authors.initials: AM
authors.lastname: Daly
authors.forename: Craig
authors.initials: C
authors.lastname: Donnelly
authors.forename: Ruth
authors.initials: R
authors.lastname: Hardy
authors.forename: Denise
authors.initials: D
authors.lastname: Harris
authors.forename: Hayley
authors.initials: H
authors.lastname: Jackman
authors.forename: Ricky
authors.initials: R
authors.lastname: Jones
authors.forename: Amy
authors.initials: A
authors.lastname: Luan
authors.forename: Douglas
authors.initials: D
authors.lastname: McAndrew
authors.forename: Pat
authors.initials: P
authors.lastname: McGauley
authors.forename: John
authors.initials: J
authors.lastname: Pearce
authors.forename: Gemma
authors.initials: G
authors.lastname: Scotney
authors.forename: May-Ling
authors.initials: ML
authors.lastname: Yeow
mesh_terms: D000077547:Crizotinib; D016018:Least-Squares Analysis; D008698:Mesylates / Q000737:chemistry; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D011720:Pyrazoles / Q000737:chemistry; D011725:Pyridines / Q000737:chemistry; D013055:Spectrophotometry, Infrared / Q000379:methods*; D013678:Technology, Pharmaceutical / Q000379:methods*
chemical_list: D008698:Mesylates; D004364:Pharmaceutical Preparations; D011720:Pyrazoles; D011725:Pyridines; D000077547:Crizotinib