EDXRF Spectrometer Enables Data-Safe Process and Quality Control of APIs and Inorganic Impurities

The S2 PUMA energy dispersive X-ray fluorescence spectrometer (EDXRF) now comes with the 21 CFR Part 11-compliant software package enabling users to integrate the instrument seamlessly into pharmaceutical laboratory environments for process and quality control. Applications include the analysis of active pharmaceutical ingredients (APIs), product safety measures such as the quantification of inorganic impurities, and the analysis of residual compounds from metallic process catalysts.

The new software guarantees complete data integrity and authenticity with features such as electronic record keeping, electronic signatures, and automatic audit trails. The complementing instrument qualification and operational qualification package (IQ/OQ) further supports users in the pharmaceutical industry.

Based on its HighSenseTM technology, the S2 PUMA easily performs the identification and analysis of hazardous toxic trace elements and contaminants from production processes according to Pharmacopeia regulation. No matter if samples are presented as pressed pellets or in powder form, the instrument can be configured for measurements in vacuum or under helium to perfectly suit any application.

Especially in combination with the TouchControlTM interface and its unique ease-of-use for failsafe operation, the S2 PUMA becomes a vital tool for the pharmaceutical industry.

For higher workloads the compact benchtop instrument is available with an exclusive 20 position sample tray and an automatic sample grabber. The S2 PUMA is also available for integration into automated laboratory environments.

EDXRF is a reliable technology used worldwide in many industrial quality control applications and stands for high analytical accuracy and precision, simple sample preparation, fast analysis-to-results times, easy instrument operation, and lowest cost of ownership. The S2 PUMA combines all of this into one high-performing instrument.