Greater Pharmaceutical Adoption of Raman Spectroscopy with New USP Chapters

The NanoRam family of handheld Raman instruments from B&W Tek is used globally for incoming raw material identification in the pharmaceutical industry. With the growing use of handheld Raman, the pharmacopeial chapters for Raman spectroscopy have followed and added more information and guidance for system testing. The replacement of USP <1120> Raman Spectroscopy with two new chapters, USP <858> Raman Spectroscopy and USP <1858> Raman Spectroscopy – Theory and Practice went into effect, reflects the regulatory recognition of Raman spectroscopy as a valuable technology to the industry.

NanoRam and NanoRam-1064 systems are calibrated in compliance with the wavelength accuracy criteria for qualitative Raman measurements set forth by all global pharmacopeias, including the new USP <858> and <1858> chapters. The system software of the NanoRam and NanoRam-1064 includes performance validation testing using Raman shift standard materials as defined by ASTM E1840 Standard Guide for Raman Shift Standards for Spectrometer Calibration. The performance validation report shows the Raman shifts measured during the validation against the specification for the tolerances for polystyrene set forth by the USP <858>, EP, and JP Raman chapters for handheld Raman or qualitative analysis.

The NanoRam systems include a variety of sampling accessories optimised for the measurement of materials in the form of liquids, gels, powders, or solids under both a laboratory setting and demanding environmental conditions. Using the NanoRam for RMID is the first step in designing quality into pharmaceutical products by ensuring raw material quality.

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