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.
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.