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… Read more >
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… Read more >
In the midst of the COVID-19 pandemic the power of technology has emerged center stage, keeping the industry connected at a time when many ordinary avenues of communication have been cut off over safety concerns.… Read 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… Read more >
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… Read more >
Enhancing performance, mitigating risk, and improving efficiency Today, Waters introduced the Arc HPLC, a modern liquid chromatography system that replicates established test methods while delivering improved performance. HPLC has been a cornerstone of routine analytical… Read more >
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… Read more >
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
The recent nitrosamine impurity crisis has brought into question the quality of many APIs (Active Pharmaceutical Ingredients) produced and sourced for a number of popular drugs, resulting in product recalls, lost profits, and regulatory actions.… Read more >
In our most recent Method Lifecycle Management webinar held Improving Analytical Method Performance Through Quality Risk Management and a Design of Experiments Approach, Joseph A. Turpin, Director of Chromatography Products and Services at S-Matrix Corporation and Tran Pham, Business Development Manager at Waters Corporation, presented an overview of Quality by Design approaches to analytical method development (AQbD), the regulatory views on this approach, examples of design of experiments in AQbD, and case studies demonstrating software assisted AQbD method development.
