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Troubleshooting Tablets

February 23, 2010
Chemical imaging specialists at Malvern Instruments have recently published an application note demonstrating that by reverse engineering pharmaceutical tablets using data from the SyNIRgi near infrared chemical imaging (NIR-CI) system they could determine extensive and detailed information about the formulations and processing techniques used to create each dosage.

This has valuable applications in troubleshooting product failures. The application note, “NIR Chemical Imaging for Tablet Deconstruction: A Case Study for Solid Dosage Forms”, can be downloaded at www.malvern.com/nircitablets.

While high-performance liquid chromatography (HPLC) can provide basic information about a product’s makeup, the application of NIR-CI adds novel information relating to its manufacture. Using Malvern’s ISys chemical imaging analysis software to evaluate the size, shape, and proximity of chemical components, SyNIRgi’s global imaging approach provides a visual representation of a product’s composition and engineered structure.

SyNIRgi delivers robust automated sampling capabilities that deliver rapid data acquisition as well as advanced data analysis via an easy-to-use interface.

The NIR-CI technique demonstrated in Malvern’s new application note takes advantage of both SyNIRgi hardware and ISys software’s advanced features. This type of reverse engineering has demonstrated unparalleled ability to help understand product failures and can primarily be used for trouble-shooting. The wealth of chemical and physical information in a chemical image provides a fingerprint of the tablet’s production properties and ultimately, its performance. It is ideal for pharmaceutical dosage analysis and enables refined quality control.