Pharmaceutical cleaning validation using non-proximate large-area desorption electrospray ionization mass spectrometry

Rapid Communications in Mass Spectrometry

Volumn 23, Issue 1, 2009, Pages 131-137

  Soparawalla, Santosh ^a   Salazar, Gary A ^a   Perry, Richard H ^a   Nicholas, Mark ^b   Cooks, R Graham ^a  

^a PURDUE UNIVERSITY   (United States)

^b ASTRAZENECA R AND D   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

DESORPTION; ELECTROSPRAY IONIZATION; KETONES; MASS SPECTROMETRY; SURFACE REACTIONS;

AMBIENT ENVIRONMENT; CLEANING VALIDATION; DESORPTION ELECTROSPRAY IONIZATION; DESORPTION ELECTROSPRAY IONIZATION MASS SPECTROMETRIES; NEOSTIGMINE; REACTION VESSEL; REPRESENTATIVE SAMPLING; SAMPLE PREPARATION; STAINLESS STEEL SURFACE; SURFACE OF REACTION;

DRUG PRODUCTS;

EID: 60149088257     PISSN: 09514198     EISSN: 10970231     Source Type: Journal    
DOI: 10.1002/rcm.3853     Document Type: Article

References (31)

1. Takats Z, Wiseman JM, Gologan B, Cooks RG. Science 2004; 306: 471.
2. Cooks RG, Ouyang Z, Takats Z, Wiseman JM. Science 2006; 311: 1566.
3. Harris GA, Nyadong L, Fernandez FM. Analyst 2008; 133: 1297.
4. Kebarle P. J. Mass Spectrom. 2000; 35: 804.
5. Nyadong L, Green MD, De Jesus VR, Newton PN, Fernandez FM. Anal. Chem. 2007; 79: 2150.
6. Chen H, Cotte-Rodriguez I, Cooks RG. Chem. Commun. 2006; 597.
7. Cotte-Rodriguez I, Takats Z, Talaty N, Chen HW, Cooks RG. Anal. Chem. 2005; 77: 6755.
8. Busch KL, Glish GL, McLuckey SA. Mass Spectrometry/Mass Spectrometry: Techniques and Applications of Tandem Mass Spectrometry. VCH: New York, 1988; 333.
9. Takats Z, Wiseman JM, Cooks RG. J. Mass Spectrom. 2005; 40: 1261.
10. Bereman MS, Muddiman DC. J. Am. Soc. Mass Spectrom. 2007; 18: 1093.
11. Nyadong L, Late S, Green MD, Banga A, Fernández FM. J. Am. Soc. Mass Spectrom. 2008; 19: 380.
12. Chen HW, Talaty N, Takats Z, Cooks RG. Anal. Chem. 2005; 77: 6915.
13. Kauppila TJ, Wiseman JM, Ketola RA, Kotiaho T, Cooks RG, Kostiainen R. Rapid Commun. Mass Spectrom. 2006; 20: 387.
14. Williams JP, Scrivens JH. Rapid Commun. Mass Spectrom. 2005; 19: 3643.
15. Weston DJ, Bateman R, Wilson ID, Wood TR, Creaser CS. Anal. Chem. 2005; 77: 7572.
16. Leuthold LA, Mandscheff JF, Fathi M, Giroud C, Augsburger M, Varesio E, Hopfgartner G. Rapid Commun. Mass Spectrom. 2006; 20: 103.
17. Ricci C, Nyadong L, Fernandez FM, Newton PN, Kazarian S. Anal. Bioanal. Chem. 2007; 387: 551.
18. LeBlanc DA. Pharm. Tech. 1998; 22: 136.
19. LeBlanc DA. Pharm. Tech. 2000; 24: 160.
20. FDA, Guide to Inspection of Bulk Pharmaceuticals. In 1994.
21. FDA, Guide to Inspections of Validations of Cleaning Processes. In 2001.
22. Validation Master Plan Installation and Operational Qualification: Non-Sterile Process Validation, Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme: Geneva, Switzerland, 2004.
23. Mollah AH. BioPharm. Int. 2008; 21: 68.
24. Debono R, Stefanou S, Davis M, Walia G. Pharm. Tech. 2002; 26: 72.
25. Kolodisk K, Phillips H, Feng J, Molski M, Kingsmill C. Pharm. Tech. 2006; 30: 56.
26. Venter A, Cooks RG. Anal. Chem. 2007; 79: 6398.
27. Cotte-Rodriguez I, Mulligan CC, Cooks RG. Anal. Chem. 2007; 79: 7069.
28. Nefliu M, Smith JN, Venter A, Cooks RG. J. Am. Soc. Mass Spectrom. 2008; 19: 420.
29. Pasilis SP, Kertesz V, Van Berkel GJ. Anal Chem. 2007; 79: 5956.
30. Ifa DR, Manicke NE, Rusine AL, Cooks RG. Rapid Commun. Mass Spectrom. 2008; 22: 503.
31. Dixon RB, Bereman MS, Muddiman DC, Hawkridge AM. J. Am. Soc. Mass Spectrom. 2007; 18: 1844.