title: Potential metal impurities in active pharmaceutical substances and finished medicinal products - A market surveillance study.
abstract: A market surveillance study has been established by using different atomic spectrometric methods for the determination of selected elemental impurities of particular interest, to gain an overview about the quality of presently marketed drug products and their bulk drug substances. The limit tests were carried out with respect to the existing EMA guideline on the specification limits for residuals of metal catalysts or metal reagents. Also attention was given to the future implementation of two new chapters of the United States Pharmacopoeia (USP) stating limit concentrations of elemental impurities. The methods used for determination of metal residues were inductively coupled plasma-mass spectrometry (ICP-MS), inductively coupled plasma-optical emission spectrometry (ICP-OES), and atomic absorption spectrometry technologies (GFAAS, CVAAS, HGAAS). This article presents the development and validation of the methods used for the determination of 21 selected metals in 113 samples from drug products and their active pharmaceutical ingredients.
authors.affiliation: Bavarian Health and Food Safety Authority, Veterinärstr. 2, 85764 Oberschleißheim, Germany.
authors.forename: Uwe
authors.initials: U
authors.lastname: Wollein
authors.affiliation: Bavarian Health and Food Safety Authority, Veterinärstr. 2, 85764 Oberschleißheim, Germany.
authors.forename: Bettina
authors.initials: B
authors.lastname: Bauer
authors.affiliation: Bavarian Health and Food Safety Authority, Veterinärstr. 2, 85764 Oberschleißheim, Germany.
authors.forename: Renate
authors.initials: R
authors.lastname: Habernegg
authors.affiliation: Bavarian Health and Food Safety Authority, Veterinärstr. 2, 85764 Oberschleißheim, Germany. Electronic address: nicholas.schramek@lgl.bayern.de.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Schramek
mesh_terms: D004340:Drug Contamination; D008670:Metals / Q000032:analysis*; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D013054:Spectrophotometry, Atomic
chemical_list: D008670:Metals; D004364:Pharmaceutical Preparations
keywords: EMA guideline; Inductively coupled plasma-mass spectrometry; Metal catalysts; Metal reagents; Pharmaceuticals