Recent posts

Mutagenic Impurity Risk Assessment Throughout the Development and Manufacturing Process

By September 15, 2020

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 >

Categories: Pharmaceutical
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The Impact of Complex Global Supply on the Nitrosamine Crisis

By July 9, 2020

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 >

Categories: Pharmaceutical
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Webinar Highlights: Two Dimensional Liquid Chromatography (2D LC) for Impurity Analysis

By February 13, 2018

Q&A from webinar on using targeted 2D LC (RP-RP) for effective impurity analysis to address peak coelutions The Waters pharmacuetical team recently hosted a webinar discussion how two-dimentional LC can offer a solution to analyze… Read more >

Categories: Pharmaceutical
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