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 Note
PDF
AN317
Enhanced Raman Reflection Spectroscopy for Process Analytical Technology
Raman Application Note
PDF
AN327
Following a Process-Induced Transformation During Granulation Using In Situ Techniques
Raman Application Note
PDF
AN316
In Situ Crystallization Monitoring
Raman Application Note
PDF
AN301
In-line Raman Monitoring of Protein Batch Crystallization
Raman Application Note
PDF
AN325
Kinetics of a Catalytic Hydrogenation Reaction
Raman Application Note
PDF
AN300
Mechanistic Study of a Microwave-Assisted Organic Reaction
Raman Application Note
PDF
AN309
Monitoring a Pharmaceutical Crystal Transformation In Situ
Raman Application Note
PDF
AN307
Monitoring Grignard Production in Real Time
Raman Application Note
PDF
AN302
Off-Line and On-Line Raman Spectroscopy of API-Containing Extruded Films
Raman Application Note
PDF
AN312
Optimizing a Microwave-Assisted Diels–Alder Reaction with Real-Time Analytics
Raman Application Note
PDF
AN314
Quantifying Anhydrate/Hydrate Using Potential PAT In Situ Techniques
Raman Application Note
PDF
AN315
Raman Monitoring of Active Coating Composition
Raman Application Note
PDF
AN324
Raman-Based High-Throughput Screening for Version and Polymorph Identification
Raman Application Note
PDF
AN311
Rapid Monitoring of Antisolvent Addition Crystallization and Dehydration
Raman Application Note
PDF
AN308