Energy-dispersive X-ray fluorescence analysis for heavy metal determination in the pharmaceutical industry conforms to procedures described in pharmacopoeia
Based on the energy-dispersive XRF spectrometer X-Lab 2000, Spectro has developed a system that offers pharmaceutical laboratories a time saving method for multi-elemental analyses. The instrument conforms to the regulations of national and international pharmacopoeia, eg the third edition of the European Pharmacopoeia.
With this new application, Spectro provides a cost-effective solution to a considerable problem in quality assurance during the production of pharmaceutical products: the analyses procedures described in the pharmacopoeia for the determination of contaminants in some cases require extensive sample preparation and often exhibit an unsatisfactory reproducibility of the results.
In addition, numerous wet-chemical methods are proposed, each of which require the test setup to be adapted to the matrix of the sample.
Thus, the routine testing of raw and auxiliary materials, active ingredients, as well as intermediate and end products for heavy metals from a wide range of potential contamination sources, is a significant cost and time factor.
Overview analysis from sodium to uranium in 100 seconds To counter the disadvantages of conventional methods, Spectro has developed a new Spectro X-Lab 2000-based application for the pharmaceutical industry.
As a universal instrument, the energy-dispersive high-power XRF system delivers an overview analyses from sodium to uranium in 100 seconds.
The polarised excitation radiation that delivers an almost complete suppression of the spectral background, coupled with the high luminous intensity of the optical system, permits quantitative analyses of individual elements in the ng/kg range. The application-specific optimisation of the excitation system provides the analytical performance of a wavelength-dispersive spectrometer at the typical instrument price of an energy-dispersive instrument.
In addition to the standardization and acceleration of the processes for the determination of essential trace elements (eg, Fe, Cu, Zn, Cr, Se, Ca, Mg, Co, Mo, I, Si, and Mn), as well as toxic elements (Cd, Mo, Pb, Hg, As, and Sn), the X-Lab 2000 offers the advantage of minimal sample preparation.
Usually, the sample is already provided as a ground powder.
For analysis, this powder only has to be filled into a measurement cuvette.
The sample is analysed non-destructively and thus can be used for further tests in contrast to wet-chemical methods.
The Spectro X-Lab 2000 conforms to the analysis methods described in the pharmacopoeia.
