Introduction to Near-Infrared Spectroscopy: Applications in the Pharmaceutical Industry
One-Day Course E09-27: Tuesday, November 17, 2009, 8:30am – 5:00pm
Dr. Emil Ciurczak, Independent Consultant, Goldens Bridge, NY
COURSE DESCRIPTION
Near-Infrared Spectroscopy (NIRS) is a non-destructive, rapid method for determining both chemical and physical properties of pure materials (API and excipients), packaging materials, mixtures, solutions, and solid dosage forms. This course will review the theory and equipment used in NIR, the most common software packages, and some qualitative and quantitative applications.
WHO SHOULD ATTEND
This course is a good introduction to analysts, lab managers, QA/QC personnel, and any person involved with process analysis (PAT/ QbD). The course will benefit anyone considering NIR as a tool as well as analysts already performing NIR analyses. Attendees need not be a spectroscopist to benefit from the course.
TOPICS
XX Basic theory and history
• A brief history and theory
• Why NIR is different from “classic” spectrometric methods
• What can be seen and where NIR may not be best applied
XX Hardware Available
• Interference and linear variable filters
• Gratings
• Interferometers
• Acousto-Optic Tunable Filters
• MEMS
• Strengths and weaknesses of each, and where each would be best applied
XX Software and Chemometrics
• Multiple Linear Regression (MLR)
• Principal Components Analysis (PCA)
• Partial Least Squares (PLS)
• Mahalanobis Distances, Conformity Index, Spectral Matching
• Some 3rd party software available
XX Qualitative Applications
• Raw material ID/qualification (RMID)
• Clinical Trials/Counterfeiting
• Polymorphic changes
• Blend uniformity
XX Quantitative Applications
• Moisture (RM, drying, Lyophilization)
• % polymorph
• % crystallinity
RECOMMENDED TEXT
Handbook of Near-Infrared Analysis/, 3rd Edition, Burns and Ciurczak, eds., CRC Press, 2007
ABOUT THE INSTRUCTOR
Dr. Emil Ciurczak has degrees in chemistry from Rutgers and Seton Hall Universities and worked in the Pharma industry since
1970 at Ciba-Geigy, Cooper Labs (Berlex), Sandoz, Merck, and Purdue Pharma. He has also worked with or consulted for Technicon
(Bran+Leubbe), FOSS NIRSystems, Brimrose, Infrared Fiber Systems, and Control Development. Emil introduced NIR at Sandoz in 1983
and was checking all raw materials (100% container-wise testing) by 1985.
He is now an independent consultant, performing NIR, PAT and QbD applications and teaching courses in PAT and NIR in the US and
Europe; he was the 2004 recipient of the EAS NIR Award. Emil holds nine patents for NIR equipment and software.
Emil is co-author of “The Handbook of NIR Analysis” (3 editions) and “Medical and Pharmaceutical Applications of NIR.” He was a contributing
editor to Spectroscopy from 1988 to 2005, and is presently Contributing Editor for Pharmaceutical Manufacturing magazine. He
has published over 75 papers and has over 150 presented papers.
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