Method for the determination of Pd-catalyst residues in active pharmaceutical ingredients by means of high-energy polarized-beam energy dispersive X-ray fluorescence

Analytical Chemistry

Volumn 81, Issue 4, 2009, Pages 1404-1410

  Margui E ^a   Van Meel, K ^b   Van Grieken, R ^b   Buendia A ^c   Fontas C ^d   Hidalgo, M ^d   Queralt, I ^a  

^a INSTITUTE OF EARTH SCIENCES JAUME ALMERA   (Spain)

^b UNIVERSITY OF ANTWERP   (Belgium)

^c Medichem SA   (Spain)

^d UNIVERSITY OF GIRONA   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

ACTIVE PHARMACEUTICAL INGREDIENTS; BEAM ENERGIES; CALIBRATION CURVES; CALIBRATION STANDARDS; CHEMICAL TREATMENTS; DATA POINTS; DRUG CANDIDATES; HIGH ENERGIES; HUMAN USE; LIMIT OF DETECTIONS; LIMIT OF QUANTITATIONS; MATRIXES; MEDICINAL CHEMISTRIES; PD CATALYSTS; POWDERED MATERIALS; RECOVERY FACTORS; REGULATORY GUIDELINES; SIMPLE METHODS; SPECIFICATION LIMITS; TECHNICAL REQUIREMENTS; TOXIC METALS; WORKING RANGES;

CALIBRATION; CATALYSIS; CATALYSTS; DRUG PRODUCTS; ENERGY DISPERSIVE SPECTROSCOPY; FLUORESCENCE; FLUORESCENCE SPECTROSCOPY; GRAPH THEORY; LAWS AND LEGISLATION; MEASUREMENT THEORY; METAL RECOVERY; PELLETIZING; PRECIOUS METALS; SPECIFICATIONS;

PALLADIUM;

PALLADIUM; DRUG;

ARTICLE; CALIBRATION; CATALYST; CHEMICAL ANALYSIS; DRUG ANALYSIS; HIGH ENERGY POLARIZED BEAM ENERGY DISPERSIVE X RAY FLUORESCENCE; SPECTROMETRY; X RAY FLUORESCENCE; ANALYSIS; CATALYSIS; CHEMISTRY; INTERNATIONAL COOPERATION; METHODOLOGY; ORGANIZATION; PRACTICE GUIDELINE; REPRODUCIBILITY; SENSITIVITY AND SPECIFICITY; STATISTICAL MODEL; TIME;

ANALYTIC SAMPLE PREPARATION METHODS; CATALYSIS; GUIDELINES AS TOPIC; INTERNATIONALITY; LINEAR MODELS; ORGANIZATIONS; PALLADIUM; PHARMACEUTICAL PREPARATIONS; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; SPECTROMETRY, X-RAY EMISSION; TIME FACTORS;

EID: 63649090172     PISSN: 00032700     EISSN: None     Source Type: Journal    
DOI: 10.1021/ac8021373     Document Type: Article

References (22)

1. Hulse, W. L.; Grimsey, I. M.; De Matas, M. Int. J. Pharm. 2008, 349, 61-65.
2. Nageswara Rao, R.; Kumar Talluri, M. V. N. J. Pharm. Biomed. Anal. 2007, 43, 1-13.
3. Garrett, C. E.; Prasad, K. Adv. Synth. Catal. 2004, 346, 889-900.
4. Committee for medicinal products for human use (CHMP). Guideline on the Specification Limits for Residues of Metal Catalysts or Metal Reagents; Doc. No. EMEA/CHMP/SWP/4446/2000); European Medicines Agency: London, U.K., February 2008.
5. The United States Pharmacopoeia, USP30. Chemical Tests. Limit Tests. Heavy Metals; 2007, pp 146-147.
6. European Pharmacopoeia 5.0. Limit Test. Heavy Metals (Method 2.4.8); 2005, pp 104-107.
7. Lewen, N.; Mathew, S.; Schenkenberger, M.; Raglione, T. J. Pharm. Biomed. Anal. 2004, 35, 739-752.
8. Niemelä, M.; Kola, H.; Eilola, K.; Perämäki, P. J. Pharm. Biomed. Anal. 2004, 35, 433-439.
9. Lásztity, A.; Kelkó-Lévai, Á; Varga, I.; Zih-Perényi, K.; Bertalan, É. Micro-chem. J. 2002, 73, 59-63.
10. Lewne, N.; Schenkenberger, M.; Larkin, T.; Conder, S.; Brittain, H. G. J. Pharm. Biomed. Anal. 1995, 35, 879-883.
11. Jia, X.; Wang, T.; Wu, J. Talanta 2001, 54, 741-751.
12. Wang, T.; Walden, S.; Egan, R. J. Pharm. Biomed. Anal. 1997, 15, 593-599.
13. Hettipathirana, T. D. X-Ray Spectrom. 2001, 30, 330-337.
14. Spolnik, Z.; Belikov, K.; Van Meel, K.; Adriaenssens, E.; De Roeck, F.; Van Grieken, R. Appl. Spectrosc. 2005, 59, 1465-1469.
15. Van Meel, K.; Smekens, A.; Behets, M.; Kazandjian, P.; Van Grieken, R. Anal. Chem. 2007, 79, 6383-6389.
16. Van Meel, K.; Fontàs, C.; Van Grieken, R.; Queralt, I.; Hidalgo, M.; Marguí, E. J. Anal. At. Spectrom. 2008, 23, 1034-1037.
17. Marguí, E.; Fontàs, C.; Van Meel, K.; Van Grieken, R.; Queralt, I.; Hidalgo, M. Anal. Chem. 2008, 80, 2357-2364.
18. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Validation of Analytical Procedures: Text and Methodology Q2(R1); November 2005.
19. Padilla, R.; Van Espen, P.; Quintana, A. A. X-Ray Spectrom. 2004, 33, 74-82.
20. QXAS/AXIL User's Manual; International Atomic Energy Agency: Vienna, Austria, 1992.
21. Epsilon 5 User's Manual, 2nd ed.; PANalytical: Almelo, The Netherlands, March 2003.
22. Van Grieken, R. E., Markowicz, A. A., Eds.; Handbook of X-Ray Spectrometry. Methods and Techniques; Marcel Dekker, Inc.: New York, 1993.