Greater pharmaceutical adoption of Raman spectroscopy with new USP chapters

B&W Tek’s NanoRam family of handheld Raman products updated in alignment with latest USP requirements

Newark, DE February 2, 2021

The NanoRam family of handheld Raman instruments 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 optimized 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.

See more information about B&W Tek handheld Raman and USP compliance here :

  • NanoRam (785 nm excitation, and Raman shift range 176–2900 cm-1)
  • NanoRam-1064 (1064 nm excitation, and Raman shift range 176–2500 cm-1)

About B&W Tek:

B&W Tek, LLC was established in Newark, DE in 1997 as a producer of custom solutions utilizing diode lasers and diode-pumped solid state (DPSS) lasers. Over the past 23 years B&W Tek LLC has evolved as a multifaceted company with expertise in photonic laser, spectrometer, and chemometric technologies producing mobile spectroscopy solutions and laser instrumentation. Our business spans mobile spectroscopy solutions including a full line of portable Raman and handheld Raman systems, building block spectrometer and laser components for system integrators, and customized solutions for targeted application needs. B&W Tek continues to be an industry-leading, total solutions provider, coupling our core technologies with custom design and manufacturing capabilities. Our commitment to innovative solutions has made B&W Tek a leader in Raman spectroscopy solutions worldwide.

In July 2018 B&W Tek, LLC became a Metrohm group company, together becoming one of the largest solutions-providers for applied Raman spectroscopy. We provide solutions for the pharmaceuticalbiomedical, chemical, safety and security, medical devices, research and educational communities.

Contact:

Saron Penrose
Marketing
B&W Tek, LLC, Newark, DE, USA
1-855-MY-BWTEK
marketing@bwtek.com

This entry was posted in Uncategorized. Bookmark the permalink.
Share