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Performance Characteristics of Mass Spectrometry-Based Analytical Procedures for Quantitation of Nitrosamines in Pharmaceuticals: Insights from an Inter-laboratory Study.

Autor: Yang J; Office of Testing and Research, Center of Drug Evaluation and Research, US Food and Drug Administration, Saint Louis, MO 63110, USA., Kakarla R; Office of Testing and Research, Center of Drug Evaluation and Research, US Food and Drug Administration, Saint Louis, MO 63110, USA., Marzan T; Office of Testing and Research, Center of Drug Evaluation and Research, US Food and Drug Administration, Saint Louis, MO 63110, USA., Sherwin B; TGA Laboratories, 136 Narrabundah Lane, Symonston, Canberra, A.C.T 2606, Australia., George M; TGA Laboratories, 136 Narrabundah Lane, Symonston, Canberra, A.C.T 2606, Australia., Bennett J; TGA Laboratories, 136 Narrabundah Lane, Symonston, Canberra, A.C.T 2606, Australia., Basutto J; TGA Laboratories, 136 Narrabundah Lane, Symonston, Canberra, A.C.T 2606, Australia., Su Y; Health Products Laboratory Program, Regulatory Operations and Enforcement Branch, Department of Health, Government of Canada, 2301 Midland Ave, Toronto ON, M1P 4R7, Canada., Ollerenshaw J; Health Products Laboratory Program, Regulatory Operations and Enforcement Branch, Department of Health, Government of Canada, 2301 Midland Ave, Toronto ON, M1P 4R7, Canada., Morin J; Health Products Laboratory Program, Regulatory Operations and Enforcement Branch, Department of Health, Government of Canada, 2301 Midland Ave, Toronto ON, M1P 4R7, Canada., Rebière H; French National Agency for the Safety of Medicines and Health Products (ANSM), Laboratory Controls Division; 635 Rue de la Garenne, 34740 Vendargues, France., Maggio AF; French National Agency for the Safety of Medicines and Health Products (ANSM), Laboratory Controls Division; 635 Rue de la Garenne, 34740 Vendargues, France., Kermaïdic A; French National Agency for the Safety of Medicines and Health Products (ANSM), Laboratory Controls Division; 635 Rue de la Garenne, 34740 Vendargues, France., Gervela E; French National Agency for the Safety of Medicines and Health Products (ANSM), Laboratory Controls Division; 635 Rue de la Garenne, 34740 Vendargues, France., Brenier C; French National Agency for the Safety of Medicines and Health Products (ANSM), Laboratory Controls Division; 635 Rue de la Garenne, 34740 Vendargues, France., Civade C; French National Agency for the Safety of Medicines and Health Products (ANSM), Laboratory Controls Division; 635 Rue de la Garenne, 34740 Vendargues, France., Chauvey D; French National Agency for the Safety of Medicines and Health Products (ANSM), Laboratory Controls Division; 635 Rue de la Garenne, 34740 Vendargues, France., Duperray F; French National Agency for the Safety of Medicines and Health Products (ANSM), Laboratory Controls Division; 635 Rue de la Garenne, 34740 Vendargues, France., Wollein U; Department of Pharmacy (OMCL), Bavarian Health and Food Safety Authority, Veterinaerstr. 2 85764 Oberschleissheim, Germany., Conti M; Schweizerisches Heilmittelinstitut (Biol. & Pharm.), OMCL Swissmedic, Hallerstrasse 7, 3012, Bern, Switzerland., Tromp J; Schweizerisches Heilmittelinstitut (Biol. & Pharm.), OMCL Swissmedic, Hallerstrasse 7, 3012, Bern, Switzerland., Meyer S; Schweizerisches Heilmittelinstitut (Biol. & Pharm.), OMCL Swissmedic, Hallerstrasse 7, 3012, Bern, Switzerland., Wanko R; Biological Standardisation, OMCL Network & HealthCare Department (DBO), EDQM - Council of Europe - Conseil de l'Europe, 7 Allée Kastner CS 30026 F- 67081 Strasbourg, France., Wierer M; Biological Standardisation, OMCL Network & HealthCare Department (DBO), EDQM - Council of Europe - Conseil de l'Europe, 7 Allée Kastner CS 30026 F- 67081 Strasbourg, France., Bertrand M; Biological Standardisation, OMCL Network & HealthCare Department (DBO), EDQM - Council of Europe - Conseil de l'Europe, 7 Allée Kastner CS 30026 F- 67081 Strasbourg, France., Rodriguez J; Office of Testing and Research, Center of Drug Evaluation and Research, US Food and Drug Administration, Saint Louis, MO 63110, USA., Sommers C; Office of Testing and Research, Center of Drug Evaluation and Research, US Food and Drug Administration, Saint Louis, MO 63110, USA., Keire D; Office of Testing and Research, Center of Drug Evaluation and Research, US Food and Drug Administration, Saint Louis, MO 63110, USA. Electronic address: david.keire@fda.hhs.gov.

Publikováno v: Journal of pharmaceutical sciences [J Pharm Sci] 2023 Oct; Vol. 112 (10), pp. 2685-2695. Date of Electronic Publication: 2023 Jul 29.

Identification and quantification of bisphenol A and bisphenol B in polyvinylchloride and polycarbonate medical devices by gas chromatography with mass spectrometry.

Autor: Gimeno P; Agence nationale de sécurité du médicament et des produits de santé (ANSM), Direction des Contrôles (CTROL), Saint-Denis Cedex, France., Spinau C; Agence nationale de sécurité du médicament et des produits de santé (ANSM), Direction des Contrôles (CTROL), Saint-Denis Cedex, France., Lassu N; Agence nationale de sécurité du médicament et des produits de santé (ANSM), Direction des Contrôles (CTROL), Saint-Denis Cedex, France., Maggio AF; Agence nationale de sécurité du médicament et des produits de santé (ANSM), Direction des Contrôles (CTROL), Saint-Denis Cedex, France., Brenier C; Agence nationale de sécurité du médicament et des produits de santé (ANSM), Direction des Contrôles (CTROL), Saint-Denis Cedex, France., Lempereur L; Agence nationale de sécurité du médicament et des produits de santé (ANSM), Direction des Contrôles (CTROL), Saint-Denis Cedex, France.

Publikováno v: Journal of separation science [J Sep Sci] 2015 Nov; Vol. 38 (21), pp. 3727-34.

Identification and quantification of 14 phthalates and 5 non-phthalate plasticizers in PVC medical devices by GC-MS.

Autor: Gimeno P; Agence nationale de sécurité du médicament et des produits de santé (ANSM), Direction des Contrôles (CTROL), 635 rue de la Garenne, 34740 Vendargues, France. Electronic address: pascal.gimeno@ansm.sante.fr., Thomas S; Agence nationale de sécurité du médicament et des produits de santé (ANSM), Direction des Contrôles (CTROL), 635 rue de la Garenne, 34740 Vendargues, France., Bousquet C; Agence nationale de sécurité du médicament et des produits de santé (ANSM), Direction des Contrôles (CTROL), 635 rue de la Garenne, 34740 Vendargues, France., Maggio AF; Agence nationale de sécurité du médicament et des produits de santé (ANSM), Direction des Contrôles (CTROL), 635 rue de la Garenne, 34740 Vendargues, France., Civade C; Agence nationale de sécurité du médicament et des produits de santé (ANSM), Direction des Contrôles (CTROL), 635 rue de la Garenne, 34740 Vendargues, France., Brenier C; Agence nationale de sécurité du médicament et des produits de santé (ANSM), Direction des Contrôles (CTROL), 635 rue de la Garenne, 34740 Vendargues, France., Bonnet PA; Agence nationale de sécurité du médicament et des produits de santé (ANSM), Direction des Contrôles (CTROL), 635 rue de la Garenne, 34740 Vendargues, France.

Publikováno v: Journal of chromatography. B, Analytical technologies in the biomedical and life sciences [J Chromatogr B Analyt Technol Biomed Life Sci] 2014 Feb 15; Vol. 949-950, pp. 99-108. Date of Electronic Publication: 2014 Jan 02.

Trace determination of ethyl methanesulfonate in Viracept 250 mg tablets by gas chromatography-mass spectrometry.

Autor: Rebiere H; AFSSAPS - French Health Product Safety Agency - Laboratory and Control Directorate, 34740 Vendargues, France., Maggio AF, Gimeno P, Levaillant D, Civade C, Bonnet PA, Tissier MH

Publikováno v: Pharmeuropa scientific notes [Pharmeur Sci Notes] 2008 Feb; Vol. 2008 (1), pp. 17-20.