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Performance Characteristics of Mass Spectrometry-Based Analytical Procedures for Quantitation of Nitrosamines in Pharmaceuticals: Insights from an Inter-laboratory Study.
Yang, Jingyue; Kakarla, Raghavi; Marzan, Tim; Sherwin, Bill; George, Mark; Bennett, Justine; Basutto, Jose; Su, Yi; Ollerenshaw, Jason; Morin, Justin; Rebière, Hervé; Maggio, Annie-Francoise; Kermaïdic, Audrey; Gervela, Elodie; Brenier, Charlotte; Civade, Corinne; Chauvey, Denis; Duperray, Françoise; Wollein, Uwe; Conti, Massimiliano; Tromp, Jan; Meyer, Simon; Wanko, Richard; Wierer, Michael; Bertrand, Marie; Rodriguez, Jason; Sommers, Cynthia; Keire, David.
Afiliación
  • 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.
J Pharm Sci ; 112(10): 2685-2695, 2023 10.
Article en En | MEDLINE | ID: mdl-37524228
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Nitrosaminas Tipo de estudio: Risk_factors_studies Límite: Humans Idioma: En Revista: J Pharm Sci Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Nitrosaminas Tipo de estudio: Risk_factors_studies Límite: Humans Idioma: En Revista: J Pharm Sci Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos