Catalyst Monitoring

Monitoring of catalyst elements according to new USP and EU Pharmacopeia regulations is an important task during research for new API.

Total reflection X-ray fluorescence (TXRF) analysis is a rapid and cost-efficient analytical method without need for sophisticated lab infrastructure.

During the development and production of Active Pharmaceutical Ingredients (API) metal catalysts like Pt, Pd, Rh, V and other metals are often used. New regulations (USP 232, 233, ICH Q3D) strictly demand the absence of these metals in the final pharmaceutical product clearly defining permitted concentration limits. Producers are obliged to install modern analytical techniques and have to provide regular control for metal contaminants.

The TXRF spectrometer S4 T-STAR offers lowest detection limits for the control of metal catalysts. Even smallest amounts of newly designed drugs can be accurately quantified. The analysis can be started after a rapid sample preparation and element contaminations are identified without time-consuming daily calibrations. Automatic quality control procedures guarantee highest data quality during 24/7 operation. The S4 T-STAR is a compact plug and play system without need for gases, media or advanced lab infrastructure. Operation costs are negligible and basic user skills are sufficient.