We understand you are busy, needing to prioritize running instruments, reporting results and managing your laboratory to meet deadlines. We created a solution guide to explain how SCIEX systems fit in the drug development pipeline to save you time evaluating options.
Nitrosamines are a large group of N-nitroso compounds that share a common functional N-N=O group. They are produced by a chemical reaction between a nitrosating agent and a secondary or tertiary amine. Back in 2018, nitrosamines suddenly found themselves in the spotlight when they were unexpectedly detected in medications for high blood pressure. Since then, they have been found in several other prescription medications, including those for heartburn, acid reflux and diabetes, resulting in manufacturers recalling some common medications.
The combination of per- and polyfluoroalkyl substances (PFAS) testing, trace-level regulatory requirements and complex MS applications can be intimidating. In a recent webinar, now available on demand, SCIEX PFAS expert Craig Butt demonstrated how the new SCIEX 7500+ system can help make PFAS testing easier.
Meeting deadlines in a bioanalysis laboratory can be a big challenge. Older, less sensitive and less reliable LC-MS systems make it even more difficult. Even the disruption caused by the installation and validation can be disconcerting and delay decisions. Does this sound familiar?
In 1998, the US Food and Drug Administration (FDA) approved fomivirsen as the first therapeutic oligonucleotide therapeutic. This approval marked a revolution of mechanism of action discovered decades before finally coming to fruition. Since then, the landscape of chemical modifications of oligonucleotides, conjugations and formulations has evolved tremendously, contributing to improvements in stability, efficacy and safety. Today, more than a dozen antisense oligonucleotides (ASOs) and small interfering RNA (siRNA) drugs are on the market, most of which are designated as orphan drugs for treating rare genetic diseases.
The development of analytical methods for the detection and quantitation of drugs and metabolites in a range of biological matrices is a challenging process. Forensic toxicology labs need a reproducible and reliable methodology to ensure the robustness of the data and the quality of the results. They also need robust and sensitive instrumentation that can detect drugs at trace levels with high specificity, especially when it comes to novel psychoactive substances (NPS), which can be difficult to monitor and control.
Managing metabolite identification (Met ID) studies is challenging, so what is at the top of your priority list as you plan the year ahead? Ensuring you have the data needed to manage product safety, meeting deadlines, staff recruitment and training, maintaining compliance, capital expenses, or something else?
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Hello. I am setting up a new development method for analyzing toxic chemicals.
N-nitrosamine analysis has raised significant concerns in the pharmaceutical industry since 2018, when these potential carcinogens were found in several angiotensin II receptor blockers (sartans). Subsequent discoveries in ranitidine and some slow-release metformin medications prompted widespread product recalls. The industry has implemented stricter manufacturing requirements and intensified efforts to evaluate and control N-nitrosamine contamination. To meet stringent regulatory requirements, it is essential to develop effective chromatography and mass spectrometry (MS) methods for N-nitrosamine analysis. This blog addresses the challenges associated with detecting N-nitrosodimethylamine (NDMA) in metformin drug products.