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Impurities findings could enhance peptide drug safety
EpiVax and Cubrc research supports FDA guidance on impurity risk assessment in generic peptides.
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Impurities
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Novel NMR-based method could facilitate safer API manufacturing
The innovative approach for detecting nitrosamine impurities in APIs addresses limitations of traditional mass-based techniques, research says.
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Internationally-compliant framework backs rabbit pyrogen test alternative
The approach aims to support broader FDA acceptance of the monocyte activation test (MAT) as a replacement, animal-free pyrogen test.
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Novel analytical approach could aid quality control during nitrosamine analysis
The innovative approach facilitates QSRR-assisted chromatographic development for N-nitrosamine analysis in pharmaceutical products.
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In-line pharma monitoring system developed for tablet quality inspection
The novel approach could enhance quality testing applications in pharmaceutical manufacturing.
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Pharmacopeial Discussion Group releases major particulate contamination update
Revisions to the harmonised general chapter “Particulate Contamination (Q-09)” aim to improve pharmaceutical drug development.
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ICH opens consultation on Q3E drug impurities guideline on leachables
Draft publication is set to expand its frameworks for new medicinal products, including cell and gene therapies.
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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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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.
