A robust analytical method for simultaneous quantification of 13 low-molecular-weight N-Nitrosamines in various pharmaceuticals based on solid phase extraction and liquid chromatography coupled to high-resolution mass spectrometry-Reference-Cited by-同舟云学术

A robust analytical method for simultaneous quantification of 13 low-molecular-weight N-Nitrosamines in various pharmaceuticals based on solid phase extraction and liquid chromatography coupled to high-resolution mass spectrometry

Published:2024-01 Issue: Volume:192 Page:106633
ISSN:0928-0987
Container-title:European Journal of Pharmaceutical Sciences
language:en
Short-container-title:European Journal of Pharmaceutical Sciences

Author:

Planinšek Parfant Timeja^ORCID,Skube Taja,Roškar Robert^ORCID

Funder

Javna Agencija za Raziskovalno Dejavnost RS

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference42 articles.

1. A comprehensive review of sources of nitrosamine contamination of pharmaceutical substances and products;Akkaraju;Regulat. Toxicol. Pharmacol.. Acad. Press,2023

2. Solid-phase extraction and high-performance liquid chromatography mass spectrometry analysis of nitrosamines in treated drinking water and wastewater;Boyd;TrAC - Trend. Anal. Chem.,2011

3. Evaluation and optimization of a HS-SPME-assisted GC–MS/MS method for monitoring nitrosamine impurities in diverse pharmaceuticals;Chang;J. Pharmaceut. Biomed. Anal.. Elsevier B.V.,2022

4. EDQM (2020) Ph. Eur. Commission adopts a new general chapter for the analysis of N-nitrosamine impurities. Available at: https://www.edqm.eu/en/-/ph-eur-commission-adopts-a-new-general-chapter-for-the-analysis-of-n-nitrosamine-impurities (Accessed: 14 July 2023).

5. EPA (2004) ‘Method 521: determination of nitrosamines in drinking water by solid-phase extraction and capillary column gas chromatography with large volume injection and chemical ionization tandem mass spectrometry (MS/MS)’, EPA Document #: EPA/600/R-05/054, p. 47.