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Versatile Near IR Chemical Imaging System NIR Spectroscopy Chemical Imaging systems: SyNIRgi

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SyNIRgi, the latest generation of Malvern Instruments (formerly Spectral Dimensions) NIR Spectroscopy Chemical Imaging systems is the fastest, most versatile system yet. Combined with ISys® hyperspectral chemical imaging data analysis software, the integrated system provides the most powerful tool available for pharmaceutical solid dosage form characterization.

SyNIRgi produces images in which the spatial distribution of sample components is visualized. Not just solid dosage forms, but granules, powder blends, complex controlled release formulations, and much more. Coupled with ISys, these chemical images support: quantitative and reproducible analysis of API and excipient abundance (comparable to concentration); statistical information that characterizes the level of heterogeneity within the sample; API and excipient domain sizes within a finished product, granule or blend; and a variety of domain statistics, like the total number of domains, the percentage area that they cover, and the average domain size.

Applications for this include Formulation research and development following the Quality by Design guidelines, Blend monitoring, Root cause analysis, Clinical Trials Pack Screening, QA/QC, Tablet pressing anomalies and Polymorph screening and identification.

As a result NIR Chemical Imaging can significantly reduce development time and improve time to market for new chemical entities. Through the use of root cause analysis and QC it can help reduce manufacturing problems that result in QC failure and improve manufacturing efficiency. For example the SyNIRgi instrument can completely image an 8mm x 8mm tablet in about a minute collecting 81,920 NIR spectra during that time. The SyNIRgi Spectroscopy Instrument is built on solid state components, with no moving parts so it works reliably even outside of laboratory environments. ISys software, whilst containing an extensive range of chemometric and spectroscopic processing tools is easy and intuitive to use.

The combination of rugged instrumentation and easy to use software also makes this a very useful tool for Pharmaceutical QC and QA environments where minimal operator involvement but rapid generation of results is a requirement.

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