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In July 2018, the European Medicines Agency (EMA) reported the recall of a number of products containing the active pharmaceutical ingredient (API) valsartan due to contamination with a known carcinogen, dimethyl nitrosamine, also referred to as N-nitroso dimethylamine (NDMA). This action set off a chain of events that led to similar notifications of recalls for…
Since the early 2000s and the advent of the first guidance relating to mutagenic impurities developed by the European Medicines Agency (EMA), it has been necessary to assess the risk posed by mutagenic impurities. Although initially it was thought that avoidance was an option, it quickly became apparent that this was not a viable strategy. …
Learn how to bring increased confidence to your sample preparation workflows using automation, smart lab tools and electronic documentation from Waters. This blog post was revised in September 2023 to include the most up-to-date information.
OneLab, cloud-native laboratory software, allows members to securely design and implement sample preparation protocols for lab analysts. Learn more by reading this post, which was revised in September 2023 to include the most up-to-date information.
Bring increased confidence in sample preparation workflows with OneLab, which enables you to track a lab analyst’s completion of an experiment. Read this blog post, revised in September 2023 to include the most up-to-date information, to learn more!
Glycosylation is an important post-translational modification that can impact the safety and efficacy of protein therapeutics and is therefore one of the most analyzed product attributes during development and quality control. In released N-glycan analysis, glycans are cleaved from proteins via enzymatic digestion and are chemically derivatized for relative quantification by liquid chromatography coupled to fluorescence and mass spectrometry, or capillary electrophoresis with laser-induced fluorescence detection. The inherent challenges of N-glycan analysis have pushed the industry to improve upon…
When a crisis occurs, hindsight is a great teacher. Any company developing or manufacturing products that impact human health can learn from the recent nitrosamine impurity contamination of angiotensin II receptor blockers (ARBs) by reviewing their own quality processes for risks that could result in a similar contamination issue. Analytical data should assure confidence in…
From fundamental research to routine analysis, Waters’ latest innovations in mass spectrometry enable our customers to gain – and apply – insights across the scientific spectrum. Beginning with fundamental research where the focus is on unraveling molecular complexity, new enhancements to the SELECT SERIES™ Cyclic IMS now support a combination of fragmentation and imaging strategies…
Laboratory automation is quickly becoming a critical component of the modern lab, streamlining pharmaceutical, life science and analytical LC-MS workflows. Automation of routine and complex sample preparation helps minimize variability, improve traceability and simplify method transfer, ultimately bringing improved efficiency to the lab and allowing scientists to spend more time on value-added tasks. Despite this,…
The nitrosamine impurity crisis continues to be on the mind of every stakeholder involved in the development and manufacturing of affected drug products. In our interactions with key opinion leaders and those in the lab having to develop and validate nitrosamine testing methods, we’ve come across a few common questions that we want to address here
Sample handling and preparation can have a substantial effect on an analytical method’s variability and data quality. It is important to consider and address the risks associated with sample preparation as part of the method development process. This requires carefully designed and executed experiments and clear documentation in the method to give the analyst an…
Scientists that have worked with peptides understand that peptide quantification can be challenging. One of the keys to successful peptide analysis is thorough and selective sample preparation. Sample preparation improves various aspects of chromatography and mass spectrometry analyses by utilizing solid phase extraction (SPE) to chemically separate different analytes and aid in removing the interfering…