Whitepaper/App Note

Application note: Verification of pharmaceutical raw materials using the Spectrum Two N FT-NIR Spectrometer

Posted: 1 November 2017 | | No comments yet

In this application note, PerkinElmer describes how the Spectrum Two N™ FT-NIR spectrometer can be deployed using a workflow approach, suitable for a regulated environment, to overcome a range of different challenges in raw material identification…

Near-infrared (NIR) spectroscopy is an important technique for materials checking at various stages of the manufacturing process, but is particularly useful at the raw materials inspection stage. Raw materials come in a variety of physical forms including liquids, gels, and solids, requiring a versatile instrument with convenient, interchangeable sampling modules to cater to the entire range of raw materials encountered.

Rapid identification of a material by its NIR spectrum can be achieved by comparison against a series of reference spectra for that specific material, requiring the material to be both identified and discriminated from similar materials.

This application note describes how the Spectrum Two N™ FT-NIR spectrometer can be deployed using a workflow approach, suitable for a regulated environment, to overcome a range of different challenges in raw material identification while also meeting the stringent requirements of 21 CFR Part 11 compliance.

 

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