HORIBA Scientific, a global leader in the production of high-performance spectroscopy systems and solutions, announces it has validated the HORIBA Aqualog® spectrofluorometer’s performance for pharmaceutical and industrial analyses.
Aqualog A-TEEM, Industrial QC/QA Analyzer. Image Credit: HORIBA Scientific
A new note explains how HORIBA's Aqualog absorbance and fluorescence performance parameters are validated using certified NIST-traceable criteria to support compliance with respective United States Pharmacopoeia (USP) chapter guidelines.
The Aqualog is fully supported for pharmaceutical and industrial installations with a comprehensive IQ/OQ document and protocol. The IQ/OQ takes into consideration all instrument performance certifications and software functionalities associated with 21 CFR Chapter 11 compliance, as required for current Good Manufacturing Practices.
The Aqualog uses A-TEEM technology, simultaneous Absorbance-Transmission fluorescence Excitation and Emission Matrix acquisition. It is a fast and inexpensive optical technique for quantitative molecular fingerprinting.
With the Aqualog, HORIBA Scientific has created a new analytical instrument that provides quantitative molecular profiling with real-time Inner Filter Effect correction (IFE). The patented configuration of the Aqualog CCD spectrometer quickly acquires 3D fluorescence Excitation Emission Matrices (EEMs) simultaneously with the UV-VIS absorbance spectrum.
IFE correction is important because it facilitates a wider linear concentration range for fluorescence spectral component information, which is important for component identification and quantification when employing uni - or multivariate analyses commonly applied in pharmaceutical and other life science industries.
The combined fluorescence/absorbance acquisition platform has a clear path to traceable validation, following standard established protocols for each. This includes certified validation of all major absorbance and fluorescence performance specifications consistent with the US Pharmacopoeia methods, namely, USP<857> and <853>, respectively (which are part of USP 40) published guidelines.
The fluorescence spectral emission for the Aqualog is both corrected and certified using Standard Reference Materials sourced directly from NIST, namely SRMs 2940, 2942 and 2943.
For more information, and to download the brochure, please go to: www.horiba.link/aqualog-pharma
Source: https://www.horiba.com/