Flow injection combined with ICP-MS for accurate high throughput analysis of elemental impurities in pharmaceutical products according to USP <232>/<233>

Journal of Pharmaceutical and Biomedical Analysis

Volumn 95, Issue , 2014, Pages 121-129

  Fischer, Lisa ^a   Zipfel, Barbara ^a   Koellensperger, Gunda ^a   Kovac, Jessica ^b   Bilz, Susanne ^b   Kunkel, Andrea ^b   Venzago, Cornel ^b   Hann, Stephan ^a  

^a UNIVERSITY OF NATURAL RESOURCES AND LIFE SCIENCES   (Austria)

^b AQura GmbH   (Germany)

Author keywords

Elemental impurities; EP 5.20; ICP MS inductively coupled plasma mass spectrometry; Pharmaceutical products; USP <232> <233>

Indexed keywords

ARSENIC; CADMIUM; CHROMIUM; COPPER; EXCIPIENT; IRIDIUM; LEAD; MANGANESE; MERCURY; NICKEL; OSMIUM; PLATINUM; RHODIUM; RUTHENIUM; VANADIUM; ZINC; DRUG; METAL;

ACCURACY; ARTICLE; DILUTION; DRUG IMPURITY; DRUG SOLUBILITY; FLOW INJECTION ANALYSIS; LIMIT OF DETECTION; LIMIT OF QUANTITATION; MASS SPECTROMETRY; MICROWAVE RADIATION; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY CONTROL; QUANTITATIVE ANALYSIS; UNITED STATES; UNITED STATES PHARMACOPEIA; ATOMIC ABSORPTION SPECTROMETRY; DRUG CONTAMINATION; HIGH THROUGHPUT SCREENING; MEDICAL LITERATURE; PROCEDURES;

DRUG CONTAMINATION; FLOW INJECTION ANALYSIS; HIGH-THROUGHPUT SCREENING ASSAYS; MASS SPECTROMETRY; METALS; PHARMACEUTICAL PREPARATIONS; PHARMACOPOEIAS AS TOPIC; SPECTROPHOTOMETRY, ATOMIC;

EID: 84896475821     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2014.02.016     Document Type: Article

References (24)

1. Guideline on the specification for residues of metal catalysts or metal reagents - Doc. Ref. EMEA/CHMP/SWP/4446/2000 2008, European Medicines Agency, London.
2. General chapter on inorganic impurities: heavy metals - Stimuli to the revision process. Pharmacopeial Forum 2008, 34(5):1345-1348.
3. De Stefano A.J., Zaidi K., Cecil T.L., Giancaspro G.I., USP Elemental Advisory Board Elemental impurities comments and responses - stimuli to the revision process. Pharmacopeial Forum 2010, 36:36.
4. De Stefano A.J., Zaidi K., Cecil T.L., Giancaspro G.I., USP Elemental Advisory Board Elemental impurities - information - stimuli to the revision process. Pharmacopeial Forum 2010, 36:1.
5. Lasztity A., Kelko-Levai A., Varga I., Zih-Perenyi K., Bertalan E. Development of atomic spectrometric methods for trace metal analysis of pharmaceuticals. Microchem. J. 2002, 73:59-63.
6. Zachariadis G., Raidou E.S., Themelis D.G., Stratis J.A. Determination of mineral content of active dry yeast used in pharmaceutical formulations. J. Pharm. Biomed. Anal. 2002, 28:463-473.
7. Orisakwe O.E., Nduka J.K. Lead and cadmium levels of commonly administered pediatric syrups in Nigera: a public health concern?. Sci. Total Environ. 2009, 47:5993-5996.
8. Zachariadis G.A., Michos C.E. Development of a slurry introduction method for multi-element analysis of antibiotics by inductively coupled plasma atomic emission spectrometry using various types of spray chamber and nebulizer configurations. J. Pharm. Biomed. Anal. 2007, 43:951-958.
9. Wang T., Wu J., Hartman R., Jia X., Eagan R. A multi-element ICP-MS survey method as an alternative to the heavy elements limit test for pharmaceutical materials. J. Pharm. Biomed. Anal. 2000, 23:867-890.
10. Lewen N., Mathew S., Schenkenberger M., Raglione T. A rapid ICP-MS screen for heavy elements in pharmaceutical compounds. J. Pharm. Biomed. Anal. 2004, 35:739-752.
11. Dolan S.P., Nortrup D.A., Bolger P.M., Capar S.G. Analysis of dietary supplements for arsenic, cadmium, mercury, and lead using inductively coupled plasma mass spectrometry. J. Agric. Food Chem. 2003, 51:1307-1312.
12. Tu Q., Wang T., Welch C.J. High-throughput metal screening in pharmaceutical samples by ICP-MS with automated flow injection using a modified HPLC configuration. Pharm. Biomed. Anal. 2010, 51:90-95.
13. Arantes De Carvalho G.G., Nunes L.C., Florencio De Souza P., Krug F.J., Correia Alegre T., Antos D. Evaluation of laser induced breakdown spectroscopy for the determination of macro and micronutrients in pharmaceutical tablets. J. Anal. At. Spectrom. 2010, 25:803-809.
14. Arzhantsev S., Li X., Kauffman J.F. Rapid limit tests for metal impurities in pharmaceutical materials by X-ray fluorescence spectroscopy using wavelet transform filtering. Anal. Chem. 2011, 83:1061-1068.
15. Margui E., Queralt I., Hidalgo M. Determination of platinum group metal catalyst residues in active pharmaceutical ingredients by means of total reflection X-ray spectrometry. Spectrochim. Acta Part B 2013, 86:50-54.
16. Kelko-Levai A., Varga I., Zih-Perenyi K., Laszity A. Determination of trace elements in pharmaceutical substances by graphite furnace atomic absorption spectrometry and total reflection X-ray fluorescence after flow injection ionexchange preconcentration. Spectrochim. Acta Part B 1999, 54:827-833.
17. Van Hoecke K., Catry C., Vanhacke F. Optimization of sample preparation and a quadrupole ICP-MS measurement protocol for the determination of elemental impurities in pharmaceutical substances in compliance with USP guidelines. J. Anal. At. Spectrom. 2012, 29:1909-1919.
18. Degussa AG - Frankfurt Germany Edelmetall-Taschenbuch 1995, 256. Hüthig Verlag, Heidelberg. 2nd edition.
19. Sauerbrunn R.D., Sandell E.B.J. Photometric determination of osmium with thiourea after extraction of the tetroxide. Anal. Chim. Acta 1953, 9:86-90.
20. Sauerbrunn R.D., Sandell E.B.J. The reaction of osmium tetroxide with thiourea. Am. Chem. Soc. 1953, 75:3554-3556.
21. Losev V.N., Bakhtina M.P., Bakhvalova I.P., Trofimchuk A.K., Runov V.K. Regularities in the sorption recovery of osmium in various oxidation states (VIII, VI, and IV) on silica chemically modified with thiourea derivatives. Anal. Chem. 2001, 56:341-347.
22. Venzago C., Popp M., Kovac J., Kunkel A. Pharmacopeial requirements for elemental impurities: a novel approach in the trace determination of osmium by oxidative pressure vessel sample digestion and measurement using inductively coupled plasma mass spectrometry (ICP-MS) after complexation and stabilisation. J. Anal. At. Spectrom. 2013, 28:1125-1129.
23. ASTM Standard D1193 Standard Specification for Reagent Water 1998, ASTM International, West Conshohocken, PA.
24. McGuffin V.L. Fundamentals and applications of chromatography and related differential migration methods. Chromatography 2004, 33. Elsevier, Amsterdam. 6th edition. E. Heftmann (Ed.).