Raw Material Identification of Pharmaceuticals Using QA and QC Analytical Instruments

Quality assurance (QA) and quality control (QC) are important in the pre-production stage of pharmaceutical production, so as to verify that the raw materials do not contain impurities that can cause health hazards or more complex purifications and lower yields.

Raw material ID is the process of evaluating these raw materials to identify and discard any impurities or adulterants that could have an adverse effect on the final product.

Bruker offers a variety of QA and QC analytical instruments to perform raw material ID using a variety of different techniques.

FT-IR and FT-NIR Spectroscopy

FT-IR and FT-NIR spectroscopy are non-destructive techniques applied in material identification. These approaches are regularly used for raw material ID as they do not need any sample preparation or harmful chemicals.

Bruker Optics supplies a variety of NIR spectrometers ideal for raw material identification.

The ALPHA, based on Bruker Optics’ patented RockSolid™ design, is a compact and user-friendly FT-IR spectrometer. If contamination is detected or if the identity check of a material fails, the unknown sample can be identified using the ALPHA by looking for the measured spectrum in the spectra library.

The MPA FT-NIR spectrometer enables users to validate several sampling techniques to discover the ideal option for QA. Fitted with fiber optic probes, the MATRIX-F and MPA FT-NIR spectrometers can be used for direct analysis of raw materials in their containers.

Raman Spectroscopy

Raman spectroscopy is typically the method of choice for raw material identification as it has many capabilities, including the ability to analyze materials directly through transparent packaging and the need for no sample preparation.

BRAVO handheld Raman spectrometer from Bruker overcomes the limitations of fluorescence or safety concerns commonly associated with handheld Raman spectroscopy.

The analytical instrument is designed with a large touch screen and a simple workflow, making QC in raw material ID easy to accomplish.

X-Ray Diffraction

X-ray diffraction (XRD) is a non-destructive rapid analytical method that can be applied in raw material identification to provide QC for the pharmaceutical sector.

The D8 ADVANCE Family includes analytical instruments enhanced for performing one analytical operation and multi-purpose solutions capable of handling various analytical requirements.

The D2 PHASER diffractometer is designed for the identification of powdered raw materials used in the pharmaceutical sector. This analytical instrument is the price and performance leader for X-ray powder diffraction in QC applications.

The D8 ENDEAVOR is another diffractometer designed to handle powder applications. This system is compatible to multi-user operation in the pharmaceutical sector, for applications such as QC and raw material ID.

This information has been sourced, reviewed and adapted from materials provided by Bruker Optics.

For more information on this source, please visit Bruker Optics.

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