Applicability of total reflection X-ray fluorescence (TXRF) as a screening platform for pharmaceutical inorganic impurity analysis

Journal of Pharmaceutical and Biomedical Analysis
Bradley J ShawMeredith R Beebe

Abstract

Palladium (Pd) is extensively used in pharmaceutical small molecule drug substance processes, however it must be removed prior to release of the active pharmaceutical ingredient (API). Evaluation of four TXRF instruments and configurations were compared to ICP-MS instrumentation for trace metal analysis, most importantly for Pd. Standards and six pharmaceutical drug substances, triprolidine HCl, diphenhydramine HCl, chlorpheniramine maleate, pseudoephedrine HCl, ephedrine sulfate, and scopolamine HBr, were analyzed to determine linearity, sensitivity, accuracy, and precision for Pd plus Cr, Fe, Cu, Rh, and Pt versus interferences, particularly from Cl, S, and Ar, on the various X-ray fluorescence lines. Irrespective of instrument platform, in general X-ray sources capable of accessing Pd-K lines were found to be most effective in determination of Pd in APIs.

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Citations

Dec 19, 2012·Journal of Pharmaceutical and Biomedical Analysis·Carlos Eduardo R de PaulaRicardo J Cassella
Mar 30, 2016·Analytical and Bioanalytical Chemistry·Juliano S BarinErico M M Flores
Sep 12, 2016·Environmental Science and Pollution Research International·Marco NataliJean -Christophe Lata
Feb 14, 2013·ACS Medicinal Chemistry Letters·Johannes C HermannQing-Fen Gan
Mar 19, 2014·Analytical Chemistry·Tom Vander HoogerstraeteKoen Binnemans

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