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

被引：5

作者：

Clegg, Ian M. ^{[1
]}

Daly, Adrian M. ^{[4
]}

Donnelly, Craig ^{[1
]}

Hardy, Ruth ^{[2
]}

Harris, Denise ^{[1
]}

Jackman, Hayley ^{[2
]}

Jones, Ricky ^{[2
]}

Luan, Amy ^{[2
]}

McAndrew, Douglas ^{[2
]}

McGauley, Pat ^{[3
]}

Pearce, John ^{[2
]}

Scotney, Gemma ^{[2
]}

Yeow, May-Ling ^{[2
]}

机构：

[1] Sandwich Labs, Pfizer World Wide Res & Dev, PTx Pharmaceut Sci, Analyt Dev, Sandwich CT13 9NJ, Kent, England

[2] Sandwich Labs, Pfizer World Wide Res & Dev, PTx Pharmaceut Sci, Chem Res & Dev, Sandwich CT13 9NJ, Kent, England

[3] Pfizer Global Supply, Technol & Innovat, Cork, Ireland

[4] Pfizer Global Supply, Proc Analyt Sci Grp, Cork, Ireland

来源：

APPLIED SPECTROSCOPY | 2012年 / 66卷 / 05期

关键词：

Process analytical technology; PAT; Mid-infrared spectroscopy; Process development; Crizotinib; 6-HYDROXYBUSPIRONE;

D O I：

10.1366/11-06380

中图分类号：

TH7 [仪器、仪表];

学科分类号：

0804 ; 080401 ; 081102 ;

摘要：

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.

引用

页码：574 / 579

页数：6

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