Pharmaceutical

Raman spectroscopy has become established in many pharmaceutical research and analytical laboratories.  Applications benefiting from Raman are plentiful, and extend from screening in early phase Discovery to final product testing in Manufacturing.  Due to the high-information content contained in the Raman spectrum, chemical and in some cases physical information regarding the material under investigation can be obtained.

This information can be critical to the goals of product quality and manufacturing robustness by generating process understanding.  The US Food and Drug Administration (FDA) recent initiative in Process Analytical Technology (PAT) and Quality by Design (QbD) manufacturing encourages the application of tools and methodologies to ensure product quality within the pharmaceutical industry by providing a framework for quality by design.
 

API Applications Include:
  • Screening of New Drug Entities Using High Throughput Screening (HTS) Techniques
  • Cystallization
  • Polymorphic Form ID
  • Real-time Reaction Analysis and Optimization
  • End-point and Intermediate Detection
  • Hydrate / Solvate, Salt Detection and ID
  • Drying
 

Drug Product Applications Include:

  • Raw Material Identification on the Dock, at the Dispensary, and at the Hopper
  • Real-time Monitoring of Granulation, Blending, Drying, and Coating
  • Non-destructive Tablets, Gel-caps, and Liquid Formulation Analysis
 
 

Contact a Kaiser Expert to discuss your applications needs.

Further information on pharmaceutical Raman applications can be found in Handbook of Raman Spectroscopy:  From Laboratory to Process Line by Ian R. Lewis and Howell G. M. Edwards, Marcel Dekker, New York, New York (2001) and Pharmaceutical Applications of Raman Spectroscopy by Sobodan Sasic, John Wiley and Sons, Hoboken, New Jersey (2008)

Additional articles outlining the utility of Raman for pharmaceutical analysis and manufacturing can be found at the American Pharmaceutical Review website. www.americanpharmaceuticalreview.com

Application Resources
Title Category Format ID#  
Comparing PhAT System™ and RamanRxn1™ Approaches for the Study of Wet Granulation Raman Application Notes PDF AN317
Following a Process-Induced Transformation During Granulation Using In Situ Techniques Raman Application Notes PDF AN316
In-line Raman Monitoring of Protein Batch Crystallization Raman Application Notes PDF AN325
Kinetics of a Catalytic Hydrogenation Reaction Raman Application Notes PDF AN300
Mechanistic Study of a Microwave-Assisted Organic Reaction Raman Application Notes PDF AN309
Monitoring a Pharmaceutical Crystal Transformation In Situ Raman Application Notes PDF AN307
Monitoring Grignard Production in Real Time Raman Application Notes PDF AN302
Off-Line and On-Line Raman Spectroscopy of API-Containing Extruded Films Raman Application Notes PDF AN312
Optimizing a Microwave-Assisted Diels–Alder Reaction with Real-Time Analytics Raman Application Notes PDF AN314
Quantifying Anhydrate/Hydrate Using Potential PAT In Situ Techniques Raman Application Notes PDF AN315
Raman Monitoring of Active Coating Composition Raman Application Notes PDF AN324
Raman-Based Endpoint Detection of a Heterogeneous Etherification Reaction Raman Application Notes PDF AN329
Rapid Monitoring of Antisolvent Addition Crystallization and Dehydration Raman Application Notes PDF AN308
Real-Time Quality Prediction of Continuously Produced Pharmaceutical Granules Raman Application Notes PDF AN330
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