Raman Spectroscopy

Leader, Nancy L. Jestel Global Spectroscopy Functional

doi:10.1002/9780470689592.ch7

Cited by 9 publications

(3 citation statements)

References 218 publications

(169 reference statements)

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“…13 Raman spectroscopy had also received attention as a PAT tool. 14,15 Raman spectroscopy has been shown to be a useful technique in API and dosage form development and manufacture. Raman spectroscopy has been used to determine amorphous, polymorphic, and pseudopolymorphic API forms.…”

Section: Introductionmentioning

confidence: 99%

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Effect of Tapped Density, Compacted Density, and Drug Concentration on Light-Induced Fluorescence Response as a Process Analytical Tool

Shah

Ely

Stagner

2015

Journal of Pharmaceutical Sciences

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Section: Introductionmentioning

confidence: 99%

“…Raman spectroscopy has been used to determine amorphous, polymorphic, and pseudopolymorphic API forms. 14,16 It has also been used to monitor API crystallization, wet granulation, emulsion, and gel manufacturing processes. 16,17 Far-infrared spectroscopy is finding increased interest and application as a potential PAT process analyzer.…”

Section: Introductionmentioning

confidence: 99%

Effect of Tapped Density, Compacted Density, and Drug Concentration on Light-Induced Fluorescence Response as a Process Analytical Tool

Shah

Ely

Stagner

2015

Journal of Pharmaceutical Sciences

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“…Common tools that are routinely used in manufacturing include thermocouples and pressure sensors. Spectroscopic tools (e.g., near-infrared, − mid-infrared, − Raman, − UV − and NMR) − are utilized for increased analytical specificity (ability to monitor for the presence or disappearance of functional groups during the synthesis). By monitoring these specific functional groups, qualitative trending or quantitative assessment of the reaction component(s) levels is achieved.…”

Section: Introductionmentioning

confidence: 99%

Industry Perspectives on Process Analytical Technology: Tools and Applications in API Development

Chanda

Daly

Foley

et al. 2014

Org. Process Res. Dev.

141

116

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The IQ Consortium reports on the current state of process analytical technology (PAT) for active pharmaceutical ingredient (API) development in branded pharmaceutical companies. The article uses an API process workflow (process steps from raw material identification through to finished API) to provide representative examples, including why and how the pharmaceutical industry uses PAT tools in API development. The use of PAT can improve R&D efficiency and minimize personnel hazards associated with sampling hazardous materials for in-process testing. Although not all steps or chemical processes are readily amenable to the use of the PAT toolbox, when appropriate, PAT enables reliable and rapid (real or near time) analyses of processes that may contain materials that are highly hazardous, transient, or heterogeneous. These measurements can provide significant data for developing process chemistry understanding, and they may include the detection of previously unknown reaction intermediates, mechanisms, or relationships between process variables. As the process becomes defined and understanding is gained through these measurements, the number of parameters suspected to be critical is reduced. As the process approaches the commercial manufacturing stage and the process design space is established, a simplification of the monitoring and control technology, as much as is practical, is desired. In many cases, this results in controls being either off-line, or if in situ control is required, the results from PAT are correlated with simple manufacturing measurements such as temperature and pressure.

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Raman Spectroscopy in Process AnalysisUpdate based on the original article by M. Anne Leugers and Elmer D. Lipp,Encyclopedia of Analytical Chemistry, © 2000, John Wiley & Sons, Ltd.

Lipp

Leugers

Chen

et al. 2012

Encyclopedia of Analytical Chemistry

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Process analysis involves the on‐line measurement of chemical or physical properties of a process, generally a manufacturing process, which provides timely data so that the process can be monitored and conditions adjusted if necessary. As a tool for process analysis, Raman spectroscopy has some desirable attributes. Foremost among these are the options for sampling. The use of visible and near‐infrared (NIR) light for the Raman measurement allows the use of commonly available fiber optics for both delivery of light to a sampling point, and then collection of the scattered light and return to a spectrometer. The probes can be insertable into a process or fully noncontact. The noncontact probes operate through windows on the process and provide one of the few means of collecting analytical information without disturbing the process. Raman spectra often provide a high level of chemical and structural information, and the seconds to minutes time frame of the measurement is well suited to process control. In this article, we discuss modern Raman instrumentation and provide a number of application examples, both conventional manufacturing processes and unconventional applications, where the principles and goals of process analysis still apply.

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Raman Spectroscopy

Cited by 9 publications

References 218 publications

Effect of Tapped Density, Compacted Density, and Drug Concentration on Light-Induced Fluorescence Response as a Process Analytical Tool

Effect of Tapped Density, Compacted Density, and Drug Concentration on Light-Induced Fluorescence Response as a Process Analytical Tool

Industry Perspectives on Process Analytical Technology: Tools and Applications in API Development

Raman Spectroscopy in Process AnalysisUpdate based on the original article by M. Anne Leugers and Elmer D. Lipp,Encyclopedia of Analytical Chemistry, © 2000, John Wiley & Sons, Ltd.

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