The Epsilon 4, an energy dispersive X-ray fluorescence (EDXRF) benchtop spectrometer, offers non-destructive elemental analyses of impurities in active pharmaceutical ingredients and excipients in line with the recommendations in ICH Q3D, USP, USP and USP. Applications that have traditionally been performed by ICP and AAS are now possible without the need for time-consuming and costly sample preparation.
Analyze accurately and frequently
To comply with regulatory requirements like ICH Q3D and USP, Malvern Panalytical offers a range of cellulose-based system calibration standards for toxic elements, catalyst residues or PGM particles. Support for validation and data integrity requirements is provided through system IQ and OQ packages and Enhanced Data Security software for user authentication and analysis auditing (FDA 21 CFR Part 11). FingerPrint, a positive material identification solution, is available for the analysis of impurities and detection of possible counterfeit drugs.
Illustrated below are the significant added values achievable by Epsilon 4, relative to this single modest investment.
Features
The power of benchtop XRF
Combining the latest excitation and detection technologies and smart design, the analytical performance of Epsilon 4 approaches that of more powerful and floor-standing spectrometers. Selective excitation and careful matching of the X-ray tube output to the capabilities of the detection system underlie the system’s outstanding performance.
Low running costs
Epsilon 4 does not require the use of expensive acids, gasses and fume hoods, like in ICP and AAS.