Analyzer Complies with New Raman Calibration Standards

June 2, 2016

PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-06-07-2016, Volume 11, Issue 6

Rigaku Analytical Devices’ Progeny 1064nm handheld Raman analyzer is compliant with the new calibration standards published by the European Pharmacopeia .

The demand for rapid identification of raw materials has led to improvements in handheld Raman instruments.

Rigaku Analytical Devices’ Progeny 1064nm handheld Raman analyzer is compliant with the new calibration standards published by the European Pharmacopeia (EP) in Supplement 8.7, Chapter 2.2.48 in October 2015 and effective April 1, 2016.

New regulations set acceptable Raman wavelength shifts and associated tolerances for benchtop and handheld Raman instruments for pharmaceutical applications.

The device  overcomes sample-induced fluorescence interference through the use of a 1064nm excitation laser, which also enables measurements to be taken through packaging. The device facilitates regulatory compliance by providing a IQ/OQ/PQ protocol package, compliant 21 CFR Part 11 digital signatures and an integrated camera for barcode reading to ensure error-free data entry.

Source: Rigaku Analytical Devices