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

doi:10.1016/j.xphs.2023.07.022

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

Journal Article · Sun Oct 01 00:00:00 EDT 2023 · Journal of Pharmaceutical Sciences

DOI:https://doi.org/10.1016/j.xphs.2023.07.022· OSTI ID:1995846

; ; Marzan, Tim; Sherwin, Bill; ; Bennett, Justine; Basutto, Jose; Su, Yi; Ollerenshaw, Jason; Morin, Justin; ; Maggio, Annie-Francoise; Kermaïdic, Audrey; Gervela, Elodie; ; Civade, Corinne; Chauvey, Denis; Duperray, Françoise; ; Conti, Massimiliano more »

Not Available

View Journal Article

Sponsoring Organization:: USDOE

OSTI ID:: 1995846

Journal Information:: Journal of Pharmaceutical Sciences, Journal Name: Journal of Pharmaceutical Sciences Journal Issue: 10 Vol. 112; ISSN 0022-3549

Publisher:: ElsevierCopyright Statement

Country of Publication:: United States

Language:: English

References (20)

A Critical N-Nitrosamine Impurity of Anticoagulant Drug, Rivaroxaban: Synthesis, Characterization, Development of LC–MS/MS Method for Nanogram Level Quantification Baksam, Vijaya Kumar; Saritha, Nimmakayala; Devineni, Subba Rao Chromatographia, Vol. 85, Issue 1 https://doi.org/10.1007/s10337-021-04115-x	journal	January 2022
Set-up and evaluation of interlaboratory studies Vander Heyden, Yvan; Smeyers-Verbeke, Johanna Journal of Chromatography A, Vol. 1158, Issue 1-2 https://doi.org/10.1016/j.chroma.2007.02.053	journal	July 2007
NDMA analytics in metformin products: Comparison of methods and pitfalls Fritzsche, Matthias; Blom, Giorgio; Keitel, Judith European Journal of Pharmaceutical Sciences, Vol. 168 https://doi.org/10.1016/j.ejps.2021.106026	journal	January 2022
NDMA impurity in valsartan and other pharmaceutical products: Analytical methods for the determination of N-nitrosamines Parr, Maria Kristina; Joseph, Jan F. Journal of Pharmaceutical and Biomedical Analysis, Vol. 164 https://doi.org/10.1016/j.jpba.2018.11.010	journal	February 2019
Interlaboratory study of a supercritical fluid chromatography method for the determination of pharmaceutical impurities: Evaluation of multi-systems reproducibility Dispas, Amandine; Clarke, Adrian; Grand-Guillaume Perrenoud, Alexandre Journal of Pharmaceutical and Biomedical Analysis, Vol. 203 https://doi.org/10.1016/j.jpba.2021.114206	journal	September 2021
Nitrosamine Contamination in Pharmaceuticals: Threat, Impact, and Control Tuesuwan, Bodin; Vongsutilers, Vorasit Journal of Pharmaceutical Sciences, Vol. 110, Issue 9 https://doi.org/10.1016/j.xphs.2021.04.021	journal	September 2021
Evaluation of analytical methods used for regulation of foods and drugs Horwitz, William. Analytical Chemistry, Vol. 54, Issue 1 https://doi.org/10.1021/ac00238a002	journal	January 1982
Potential for the Formation of N-Nitrosamines during the Manufacture of Active Pharmaceutical Ingredients: An Assessment of the Risk Posed by Trace Nitrite in Water Ashworth, Ian W.; Dirat, Olivier; Teasdale, Andrew Organic Process Research & Development, Vol. 24, Issue 9 https://doi.org/10.1021/acs.oprd.0c00224	journal	August 2020
Development of a Sensitive Headspace Gas Chromatography–Mass Spectrometry Method for the Simultaneous Determination of Nitrosamines in Losartan Active Pharmaceutical Ingredients Wichitnithad, Wisut; Sudtanon, Orawan; Srisunak, Pawadee ACS Omega, Vol. 6, Issue 16 https://doi.org/10.1021/acsomega.1c00982	journal	April 2021
Current developments in LC-MS for pharmaceutical analysis Beccaria, Marco; Cabooter, Deirdre The Analyst, Vol. 145, Issue 4 https://doi.org/10.1039/C9AN02145K	journal	January 2020
Analysis of nine nitrosamines in water by combining automated solid-phase extraction with high-performance liquid chromatography-atmospheric pressure chemical ionisation tandem mass spectrometry Lee, Ji-Hyun; Lee, Sung-Uk; Oh, Jeong-Eun International Journal of Environmental Analytical Chemistry, Vol. 93, Issue 12 https://doi.org/10.1080/03067319.2013.803281	journal	October 2013
Regulatory Updates and Analytical Methodologies for Nitrosamine Impurities Detection in Sartans, Ranitidine, Nizatidine, and Metformin along with Sample Preparation Techniques Shaik, Khaja Moinuddin; Sarmah, Bhaskar; Wadekar, Gaurav Suresh Critical Reviews in Analytical Chemistry, Vol. 52, Issue 1 https://doi.org/10.1080/10408347.2020.1788375	journal	July 2020
Quantitative mass spectrometry methods for pharmaceutical analysis Loos, Glenn; Van Schepdael, Ann; Cabooter, Deirdre Philosophical Transactions of the Royal Society A: Mathematical, Physical and Engineering Sciences, Vol. 374, Issue 2079 https://doi.org/10.1098/rsta.2015.0366	journal	October 2016
N ‐nitrosodimethylamine‐Contaminated Valsartan and Risk of Cancer: A Nationwide Study of 1.4 Million Valsartan Users Mansouri, Imène; Botton, Jeremie; Semenzato, Laura Journal of the American Heart Association, Vol. 11, Issue 24 https://doi.org/10.1161/JAHA.122.026739	journal	December 2022
Valsartan recall: global regulatory overview and future challenges Farrukh, Muhammad Junaid; Tariq, Muhammad Haseeb; Malik, Obaidullah Therapeutic Advances in Drug Safety, Vol. 10 https://doi.org/10.1177/2042098618823458	journal	January 2019
A Cautionary Tale: Quantitative LC-HRMS Analytical Procedures for the Analysis of N-Nitrosodimethylamine in Metformin Yang, Jingyue; Marzan, Tim Andres; Ye, Wei The AAPS Journal, Vol. 22, Issue 4 https://doi.org/10.1208/s12248-020-00473-w	journal	July 2020
International Regulatory Collaboration on the Analysis of Nitrosamines in Metformin-Containing Medicines Keire, David A.; Bream, Robert; Wollein, Uwe The AAPS Journal, Vol. 24, Issue 3 https://doi.org/10.1208/s12248-022-00702-4	journal	April 2022
The International Harmonized Protocol for the proficiency testing of analytical chemistry laboratories (IUPAC Technical Report) Thompson, Michael; Ellison, Stephen L. R.; Wood, Roger Pure and Applied Chemistry, Vol. 78, Issue 1 https://doi.org/10.1351/pac200678010145	journal	January 2006
Development and Validation for Quantification of 7-Nitroso Impurity in Sitagliptin by Ultraperformance Liquid Chromatography with Triple Quadrupole Mass Spectrometry Chittireddy, Hari Naga Prasada Reddy; Kumar, J. V. Shanmukha; Bhimireddy, Anuradha Molecules, Vol. 27, Issue 23 https://doi.org/10.3390/molecules27238581	journal	December 2022
A multi-analyte LC-MS/MS method for screening and quantification of nitrosamines in sartans Chang, Shu-Han; Chang, Ching-Chia; Wang, Li-Jing Journal of Food and Drug Analysis, Vol. 28, Issue 2 https://doi.org/10.38212/2224-6614.1063	journal	June 2020

Similar Records

Quantification of phospholipid degradation products in liposomal pharmaceutical formulations by ultra performance liquid chromatography-mass spectrometry (UPLC-MS)

Journal Article · Sat Feb 29 23:00:00 EST 2020 · International Journal of Pharmaceutics · OSTI ID:2280090

Bacterial Analysis by MALDI-TOF Mass Spectrometry: An Inter-laboratory Comparison

Journal Article · Thu Mar 31 23:00:00 EST 2005 · Journal of the American Society for Mass Spectrometry · OSTI ID:15016046

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

Citation Formats

References (20)

Similar Records

Related Subjects