Assessment of metal elements in final drug products by wavelength dispersive X-ray fluorescence spectrometry

被引：7

作者：

Goncalves, Luisa M. L. ^{[1
]}

Costa, Isabel M. ^{[1
]}

Brito, Jose A. A. ^{[1
]}

机构：

[1] Inst Super Ciencias Saude Egas Moniz, P-2829511 Quinta Da Granja, Caparica, Portugal

来源：

ANALYTICAL METHODS | 2011年 / 3卷 / 07期

关键词：

D O I：

10.1039/c1ay05133d

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

This work demonstrates that an analytical method based on wavelength dispersive X-ray fluorescence spectrometry has an acceptable degree of linearity, precision and accuracy in a given range, which make it suitable for the purpose of determining Cu, Zn, Fe and Cr impurities in final drug products.

引用

页码：1468 / 1470

页数：3

共 8 条

[1] Metal Impurities in Food and Drugs
Abernethy, Darrell R.
DeStefano, Anthony J.
Cecil, Todd L.
Zaidi, Kahkashan
Williams, Roger L.
[J]. PHARMACEUTICAL RESEARCH, 2010, 27 (05) : 750 - 755
[2] Alexander J, 2008, EFSA J, V6, DOI 10.2903/j.efsa.2008.653
[3] [Anonymous], 2010, INT PHARM
[4] [Anonymous], 2008, EUR PHARM
[5] [Anonymous], 2005, INT C HARMONISATION, P1
[6] DeStefano A. J., 2010, PHARMACOPEIAL FORUM, V36, P1
[7] Determination of metal residues in active pharmaceutical ingredients according to European current legislation by using X-ray fluorescence spectrometry
Margui, E.
Fontas, C.
Buendia, A.
Hidalgo, M.
Queralt, I.
[J]. JOURNAL OF ANALYTICAL ATOMIC SPECTROMETRY, 2009, 24 (09) : 1253 - 1257
[8] 2010, USP33NF28

← 1 →