Revised Pharmacopoeia Chapter on Raman Spectroscopy in Ph. Eur. 10.7 and USP <858> & <1858>.
Pharmacopeia state pharmaceutical norms, recommend analytical methods for quality control (QC) of incoming goods and issue requirements for the used analytical instruments. These official standards are legally binding worldwide. Pharma compliance to the latest pharmaceutical regulations and guidelines is one of Bruker’s key strengths! Bruker’s handheld Raman spectrometer BRAVO is THE analytical solution for QC in the pharmaceutical industry.
The revised European Pharmacopoeia Chapter 2.2.48 on Raman spectroscopy was published in the Ph. Eur. Supplement 10.7 in October 2021 and will be applicable in April 2022:
A new section on spectral resolution testing with calcium carbonate was introduced. Here a maximum resolution of 15 cm-1 is specified for identity tests, which is to be monitored as a performance parameter. Alongside minor editorial improvements, the section on the response-intensity scale and qualitative methods had been revised.
It is worthwhile to mention that the United States Pharmacopoeia published as well revised chapters on Raman spectroscopy <858> & <1858>, replacing the former well established USP chapter <1120> and took effect on November 1st, 2021.
With its already high standard of performance tests, the BRAVO is fully compliant to the revised chapter in Ph. Eur. 10.7 and USP <858> & <1858>. This also applies to already installed spectrometers.
If you are interested in how the handheld Raman spectrometer BRAVO complies to current pharmaceutical guidelines and regulations, please have a look at the detailed compliance statement.
