Since the detection of N-nitrosodimethylamine (NDMA) in a batch of valsartan in 2018, at levels exceeding ICH acceptable intake limits for mutagenic impurities, the analysis of nitrosamines has become an intense focus point for the pharmaceutical industry. The identification and low...
More from the EMA on nitrosamine impurities Thermo Scientific solutions for nitrosamine impurity detection LC-HRAM Thermo Scientific Orbitrap Exploris 120 with ultimate LC confidence LC-MS/MS Thermo Scientific TSQ Quantis with ultimate LC robustness GC-HRAM Thermo Scientific Orbitrap...
Recent regulatory requirements also suggest the need to have highly sensitive analytical methods for the accurate quantification of Nitrosamine impurities. In this paper we have presented simple, rapid and ultra-sensitive LC-MS/MS method for six potential genotoxic nitrosamine impurities: N-Nitroso ...
The FDA Office of Testing and Research have developed a combined GC/MS headspace method for the simultaneous evaluation of four nitrosamine impurities in ARB drug substance and drug product. These impurities are; N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA), N-nitrosodiisopropylamine (ND...
Revisions to CEP applications should be concluded at the latest by 26thSeptember 2022. The FDA has also addressed nitrosamine testing, recognizing that the low levels of impurities present will create testing challenges. They recommend LC-HRMS (Liquid Chromatography High Resolution Mass Spectrometry) to...
High Sensitivity Quantitation of Nitrosamine Genotoxic Impurities: LC-MS Analysis of Ranitidine Drug Product using the Waters ACQUITYTM UPLCTM I-Class/Xevo... ■ Nitrosamine quantification achieving LLOQs of 0.025–0.1 ng/mL INTRODUCTION Ranitidine is a histamine-2 blocker, which decreases the amount...
Ensuring strict control measures are essential to meet regulatory guidelines related to the potential presence of mutagenic impurities in medicines, specifically nitrosamines. Waters provides accessible LC/MS and MS/MS solutions enabling the development of sensitive, accurate and robust analytical methodologies...
The paper describes the main mechanism responsible for the toxic effect of this group of impurities in human body. It also describes methods of extraction and analysis of N-nitrosamines found in medicinal products. It was demonstrated that high-performance liquid chromatography and gas chromatography-...
Nitrosamines are a family of carcinogens impurities which are formed by the reaction of secondary amines, amides, carbamates, derivatives of urea with nitrite
Employing analytical methodology and tools to identify nitrosamine impurities Element has performed nitrosamine testing in accordance with the guidance published by the FDA. Our teams of expert scientists have also developed liquid chromatography with tandem mass spectrometry (LC-MS/MS) methods for nitrosa...