A new freely downloadable presentation available via the Malvern Instruments website, highlights how SyNIRgi, the company’s near infrared chemical imaging (NIR-CI) system, can provide the data and product understanding required for Quality by Design. To download the presentation visit http://www.brainshark.com/malvern/NIR-CI_pharma.
‘Near infrared imaging of pharmaceuticals and Quality by Design’ looks at how this measurement technology can help answer the questions of “What? How much? And Where?” It presents a variety of applications in the pharmaceutical industry and a discussion of how to derive statistically meaningful, reproducible and quantitative results.
According to Malvern, SyNIRgi identifies, quantifies and locates chemical species within a sample. This information provides insight into product performance, optimizing design space definition and specification setting. Analytical times are short and no sample preparation is required, making the system a ‘go to’ option for QbD related studies.
With SyNIRgi a researcher can track water gradients in a tablet during hydration, rather than simply monitoring average water content. The distribution of active pharmaceutical ingredients (API) can be studied to assess the efficacy of blending or interactions with excipients. Coating quality – thickness, homogeneity – can be statistically measured. In each case the result is greater product and process understanding.
SyNIRgi is fully automated with the capability to analyze powders, granules, tablets or complete blister packs, in minutes. In excess of 80,000 spectra are collected from across the surface of the sample for each measurement. Advanced statistical analysis techniques, accessed via ISys, a user-friendly software package, extract relevant chemical and morphological information.