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Guide to Testing 2025
In this Guide to Testing, articles explore method validation for endotoxin testing and using advanced chromatography solutions for analytical laboratory applications.
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Impurities
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European Pharmaceutical Review Issue 2 2025
EPR Issue 2 includes articles on the impact of tariffs on the pharmaceutical supply chain, advances in bioprocessing, manufacturing and more.
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Qualification of non-mutagenic impurities (NMIs)
In this article, Dave Elder reviews the European Medicines Agency (EMA)’s updated reflection paper on the qualification of non-mutagenic impurities (NMIs), which outlines alternative approaches to animal testing.
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Optimal biosafety cabinet cleaning strategy proposed
The research highlights a potential approach to address cross-contamination challenges during cell-processing operations.
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EU Urban Wastewater Treatment Directive may compromise EU medicine availability
The directive could lead to nearly €1 billion in additional costs for pharmaceutical companies in Finland alone, states Orion Corporation.
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ICH Q6(R1): test criteria and specifications
Dave Elder shares industry thoughts on an ICH Q6(R1) concept paper that aims to revise general principles for uniformity and consistency across ICH Q6 guidelines for test criteria and specifications.
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New mass spectrometry Chapter could “revolutionise” biopharma quality assurance
Launch of the USP general method chapter signals a breakthrough in pharmaceutical drug impurity control, according to biopharma experts.
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MAS-100 Libra®: the future of continuous cleanroom monitoring
Microbiological monitoring is essential for pharmaceutical facilities. As regulatory standards tighten, especially in cleanroom classes A and B, the need for reliable, continuous monitoring has grown. The MAS-100 Libra meets these demands by combining traditional settle plate methods with advanced automation, improving efficiency and accuracy.
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Understanding endotoxin cartridge testing: frequently asked questions
Charles River’s Courtney Wachtel and Sherri Hopple discuss endotoxin cartridge testing, its application and how it differs from traditional BET assays.
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Downstream process shows potential for oncolytic virus purification
The paper presents an “efficient and scalable GMP-compliant process” for purifying a fusogenic oncolytic virus (rVSV-NDV).
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European Pharmacopoeia makes milestone pyrogen testing commitment
The "historic" decision from the Ph. Eur. follows publication of its texts relating to the rabbit pyrogen test (RPT) replacement strategy.
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Chromatography analysis for nitrosamine quantitation in pharmaceutical manufacturing water
The paper describes an innovative ion chromatography-based analytical method for quantifying nitrite quantities in purified and potable water.
podcasts
EPR Podcast Episode 26 – Navigating Nitrosamine Impurities – Jason Brown, Adare Pharma Solutions
In this podcast, Jason Brown, Senior Manager, Analytical Sciences, R&D, Adare Pharma Solutions, discusses the current landscape and the best approaches for mitigating contamination and detecting nitrosamines.
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Using mass spectrometry to improve quality and safety of levothyroxine
A study investigating levothyroxine has reported a new non-targeted analytical approach for pharmaceutical quality control analysis.
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Unique testing regimen could prevent nuclease contamination
Biannual routine testing in the laboratory reduces both the likelihood of nuclease contamination occurrence and its impact, a study suggests.
