Document Detail

In-Line Multipoint NIR Spectroscopy for Moisture Content Quantification during Freeze-Drying.
MedLine Citation:
PMID:  23351045     Owner:  NLM     Status:  Publisher    
During the past decade, near-infrared (NIR) spectroscopy has been applied for in-line moisture content quantification during a freeze-drying process. However, NIR has been used as a single-vial technique and thus is not representative of the entire batch. This has been considered as one of the main barriers for NIR spectroscopy becoming widely used in process analytical technology (PAT) for freeze-drying. Clearly it would be essential to monitor samples that reliably represent the whole batch. The present study evaluated multipoint NIR spectroscopy for in-line moisture content quantification during a freeze-drying process. Aqueous sucrose solutions were used as model formulations. NIR data was calibrated to predict the moisture content using partial least squares (PLS) regression with Karl Fischer titration being used as a reference method. PLS calibrations resulted in root mean square error of prediction (RMSEP) values lower than 0.13 %. Three non-contact, diffuse reflectance NIR probe heads were positioned on the freeze-dryer shelf to measure the moisture content in a non-invasive manner, through the side of the glass vials. The results showed that the detection of unequal sublimation rates within a freeze-dryer shelf was possible with the multipoint NIR system in use. Furthermore, in-line moisture content quantification was reliable especially towards the end of the process. These findings indicate that the use of multipoint NIR spectroscopy can achieve representative quantification of moisture content and hence a drying end point determination to a desired residual moisture level.
Ari Kauppinen; Maunu Toiviainen; Ossi Korhonen; Jaakko Aaltonen; Kristiina Järvinen; Janne Paaso; Mikko Juuti; Jarkko Ketolainen
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-1-28
Journal Detail:
Title:  Analytical chemistry     Volume:  -     ISSN:  1520-6882     ISO Abbreviation:  Anal. Chem.     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-1-28     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0370536     Medline TA:  Anal Chem     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
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