Impact and practicability of recently introduced requirements on elemental impurities

被引：26

作者：

Pohl, Pawel ^{[1
]}

Bielawska-Pohl, Aleksandra ^{[2
]}

Dzimitrowicz, Anna ^{[1
]}

Jamroz, Piotr ^{[1
]}

Welna, Maja ^{[1
]}

机构：

[1] Wroclaw Univ Sci & Technol, Fac Chem, Div Analyt Chem & Chem Met, Wyspianskiego 27, PL-50370 Wroclaw, Poland

[2] Polish Acad Sci, Ludwik Hirszfeld Inst Immunol & Expt Therapy, Lab Glycobiol & Cellular Interact, Weigla 12, PL-53114 Wroclaw, Poland

来源：

TRAC-TRENDS IN ANALYTICAL CHEMISTRY | 2018年 / 101卷

关键词：

Elements; Pharmaceuticals; Sample preparation; Inductively coupled plasma optical emission (ICP-OES); Inductively coupled plasma mass spectrometry (ICP-MS); ACTIVE PHARMACEUTICAL INGREDIENTS; PLASMA-MASS SPECTROMETRY; ICP-MS; HEAVY-METALS; SAMPLE PREPARATION; DIGESTION; PRODUCTS; SUBSTANCES; CHAMBER; DRUGS;

D O I：

10.1016/j.trac.2017.09.011

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

Spectrochemical elemental analysis of pharmaceuticals and raw materials used for their production will be in the nearest future an obligatory part of quality and safety control for compliance with new standards announced by the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH Q3D). The present paper surveys R&D articles and scientific papers devoted to determination of the elemental impurities by inductively coupled plasma optical emission spectrometry and mass spectrometry (ICP-OES and ICP-MS) in different pharmaceuticals products that have been published since 2000. In reference to recent changes described in the United States Pharmacopoeia (USP) general chapters < 232 > and < 233 >, different aspects of such measurements are presented, including appropriate sample preparation procedures, possible interferences and means of their avoidance, suitable calibration strategies and validation parameters that have to be assessed to prove reliability of the analytical results on the elemental impurities in pharmaceutical products. (C) 2017 Elsevier B.V. All rights reserved.

引用

页码：43 / 55

页数：13

共 54 条

[31]

Liba A., 2014, 59909382EN AG TECHN

[32]

Mangum S.J., 2010, 00907301 PERKINELMER

[33] Study and determination of elemental impurities by ICP-MS in active pharmaceutical ingredients using single reaction chamber digestion in compliance with USP requirements [J].