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

Journal Article · · Journal of Pharmaceutical Sciences

Not Available

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)

Regulatory Updates and Analytical Methodologies for Nitrosamine Impurities Detection in Sartans, Ranitidine, Nizatidine, and Metformin along with Sample Preparation Techniques journal July 2020
Interlaboratory study of a supercritical fluid chromatography method for the determination of pharmaceutical impurities: Evaluation of multi-systems reproducibility journal September 2021
A Cautionary Tale: Quantitative LC-HRMS Analytical Procedures for the Analysis of N-Nitrosodimethylamine in Metformin journal July 2020
Evaluation of analytical methods used for regulation of foods and drugs journal January 1982
NDMA analytics in metformin products: Comparison of methods and pitfalls journal January 2022
Nitrosamine Contamination in Pharmaceuticals: Threat, Impact, and Control journal September 2021
Valsartan recall: global regulatory overview and future challenges journal January 2019
Set-up and evaluation of interlaboratory studies journal July 2007
N ‐nitrosodimethylamine‐Contaminated Valsartan and Risk of Cancer: A Nationwide Study of 1.4 Million Valsartan Users journal December 2022
International Regulatory Collaboration on the Analysis of Nitrosamines in Metformin-Containing Medicines journal April 2022
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
Development and Validation for Quantification of 7-Nitroso Impurity in Sitagliptin by Ultraperformance Liquid Chromatography with Triple Quadrupole Mass Spectrometry journal December 2022
A Critical N-Nitrosamine Impurity of Anticoagulant Drug, Rivaroxaban: Synthesis, Characterization, Development of LC–MS/MS Method for Nanogram Level Quantification journal January 2022
Development of a Sensitive Headspace Gas Chromatography–Mass Spectrometry Method for the Simultaneous Determination of Nitrosamines in Losartan Active Pharmaceutical Ingredients journal April 2021
Current developments in LC-MS for pharmaceutical analysis journal January 2020
NDMA impurity in valsartan and other pharmaceutical products: Analytical methods for the determination of N-nitrosamines journal February 2019
Analysis of nine nitrosamines in water by combining automated solid-phase extraction with high-performance liquid chromatography-atmospheric pressure chemical ionisation tandem mass spectrometry journal October 2013
A multi-analyte LC-MS/MS method for screening and quantification of nitrosamines in sartans journal June 2020
The International Harmonized Protocol for the proficiency testing of analytical chemistry laboratories (IUPAC Technical Report) journal January 2006
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 journal August 2020