Genotoxic impurities: A quantitative approach

Journal of Liquid Chromatography and Related Technologies

Volumn 31, Issue 15, 2008, Pages 2318-2330

  Yuabova, Zhanna Y ^a   Holschlag, David R ^a   Rodriguez, Shirley A ^a   Qin, Cindy ^a   Papov, Vladimir V ^a   Qiu, Fenghe ^a   McCaffrey, John F ^a   Norwood, Daniel L ^a  

^a BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

Author keywords

CAD; ELSD; Genotoxic impurities; LC MS MS; Quantitation; Validation

Indexed keywords

CHEMICAL PROPERTIES; CHEMOTHERAPY; CHROMOPHORES; DRUG DELIVERY; DRUG DOSAGE; STANDARDS; ULTRAVIOLET DETECTORS;

ACTIVE PHARMACEUTICAL INGREDIENTS; ANALYTE; ANALYTICAL METHODS; ANALYTICAL TECHNIQUES; CAD; CLINICAL DEVELOPMENT; DAILY INTAKE; DETECTION TECHNIQUES; DRUG SUBSTANCES; ELSD; GENOTOXIC IMPURITIES; HPLC ANALYSIS; IMPURITY LEVELS; LC-MS/MS; ON CURRENTS; PHYSICAL AND CHEMICAL PROPERTIES; QUANTITATION; QUANTITATION LIMITS; QUANTITATIVE APPROACHES; STARTING MATERIALS; UV DETECTION; UV-ABSORBANCE; VALIDATION;

IMPURITIES;

ACCURACY; ANALYTIC METHOD; ARTICLE; DRUG IMPURITY; GENOTOXICITY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; INSTRUMENTATION; PHYSICAL CHEMISTRY; QUANTITATIVE ANALYSIS; SENSITIVITY AND SPECIFICITY; ULTRAVIOLET RADIATION;

APIS;

EID: 49449091670     PISSN: 10826076     EISSN: 1520572X     Source Type: Journal    
DOI: 10.1080/10826070802281745     Document Type: Article

References (9)

1. http://www.ilo.org/encyclopaedia/?d&nd=857400278 - Sorsa, M. Genotoxic chemicals. The International Labour Organization, Geneva, Switzerland.
2. McGovern, T.; Jacobson-Kram, D. Regulation of genotoxic and carcinogenic impurities in drug substances and products. TrAC September 2006, 25(8), 790-795.
3. The meeting of the joint pharmaceutical analysis group in association with King's College London. The Pharm. Jour. 2006, 276(7395), 422-423.
4. Guideline on the limits of genotoxic impurities. Committee for Medical Products for Human Use (CHMP). European Medicines Agency. London, 28 June, 2006, p. 28.
5. http://www.ich.org/cache/compo/363-272-1.html-International Conference on Harmonization.
6. Munro, I.C. Safety assessment procedures for indirect food additives: An overview. Report of a workshop. Regul. Toxicol. and Pharmacol. 1990, 12, 2-12.
7. Kroes, R.; Kleiner, J.; Renwick, A. The threshold of toxicological concern concept in risk assessment. Toxicol. Sci. 2005, 86(2), 226-230.
8. Muller, L.; Mauthe, R.J.; Riley, C.M.; Andino, M.M.; De Antonis, D.; Beels, C.; DeGeorge, J.; De Knaep, A.G.M.; Ellison, D.; Fegerland, J.A.; Frank, R.; Fitschel, B.; Galloway, S.; Harpur, E.; Humfrey, C.D.N.; Jacks, A.S.; Jagota, N.; Mackinnon, J.; Mohan, G.; Ness, D.K.; O'Donovan, M.R.; Smith, M.D.; Vudathala, G.; Yotti, L. A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity. Regul. Toxicol. Pharmacol. 2006, 44(3), 198-211.
9. Gamache, P.H.; McCarthy, R.S.; Freeto, S.M.; Asa, D.J.; Woodcock, M.J.; Laws, K.; Cole, R.O. HPLC analysis of non-volatile analytes using charged aerosol detection. LC-GC Europe 2005, 18(6), 341-354.