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Applicability of Total Reflection X-ray Fluorescence (TXRF) as a Screening Platform for Pharmaceutical Inorganic Impurity Analysis

Applicability of Total Reflection X-ray Fluorescence (TXRF) as a Screening Platform for Pharmaceutical Inorganic Impurity Analysis

Bradley J Shaw, David J Semin, Michael E Rider, Meredith R Beebe

J Pharm Biomed Anal. 2012 Apr 7;63:151-9.

PMID: 22349883

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.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP1246816578	Chlorpheniramine Impurity A		1246816-57-8	Price

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