title: One hundred percent online identity check of pharmaceutical products by near-infrared spectroscopy on the packaging line.
abstract: To increase product safety of pharmaceuticals, a new near-infrared (NIR) method for the online identity check of pharmaceutical finished products was validated. The method comprises a new near-infrared device VisioNIR (Uhlmann VisioTec GmbH, Laupheim, Germany) and the appropriate evaluation statistics. The VisioNIR is applied to the packaging line and provides the possibility to perform a 100% product identity check at full line speed. The products were analyzed applying near-infrared spectroscopy (900-1700 nm) in reflectance mode. The scanned products were two widely used pharmaceuticals named Capsule A (containing 300 mg of paracetamol and 250 mg of chlorzoxazone) and Capsule B (containing 500 mg of paracetamol and 30 mg of codeine phosphate). In order to demonstrate the fitness of the VisioNIR the obtained data were compared with the data acquired by Foss NIRSystems 6500 spectrometer (NIRSystems, Silver Springs, MD). The results obtained by the VisioNIR evaluation statistics were compared with the results obtained by the commonly used principal component analysis. The advantages and the suitability of the method are discussed. In this new configuration NIR spectroscopy offers an excellent possibility for non-destructive 100% online quality control of pharmaceutical products.
authors.affiliation: Department of Pharmaceutical Chemistry, Institute of Pharmaceutical Sciences, Eberhard-Karls-University, Tübingen, Germany. thorsten.herkert@uni-tubingen.de
authors.forename: T
authors.initials: T
authors.lastname: Herkert
authors.forename: H
authors.initials: H
authors.lastname: Prinz
authors.forename: K
authors.initials: K
authors.lastname: Kovar
mesh_terms: D003627:Data Interpretation, Statistical; D004349:Drug Packaging / Q000379:methods; D008956:Models, Chemical; D009862:Online Systems; D004364:Pharmaceutical Preparations / Q000032:analysis*; D011786:Quality Control; D012984:Software; D013055:Spectrophotometry, Infrared / Q000379:methods*
chemical_list: D004364:Pharmaceutical Preparations