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Pharmaceutical sterility testing market to grow from $2.07b in 2027
Research suggests that the global sterility testing market will see a nearly $200 billion increase in spending on new products in the next five years.
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Impurities
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ebook: Extractables and leachables: a guide to analytical methods
This ebook takes an in-depth look at advanced analytical methods for extractables and leachables analysis in the pharma industry.
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WHO urges supply chain to take action on contaminated medicines
Key stakeholders in the medicine supply chain have been urged by the World Health Organization to take immediate action against recent cases of contaminated medicines.
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Limiting microbial hazards in inhaled cannabis products
FDA researchers found there was some reduction in microbial counts by heating cannabis with a commercial vaporiser to limit microbial contamination, but they were not statistically significant.
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Ph. Eur. adopts revised general monographs after adding paragraph on N-nitrosamines
Adoption of revised general monographs 2034 and 2619 comes after inclusion of a new paragraph approaching N-nitrosamine impurities.
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QA of prostaglandin analogues for glaucoma treatment
Paper highlights trends in developing analytical procedures to assess the quality of prostaglandin analogues used to treat glaucoma.
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Large bacterial culture volumes can be filtered without centrifuge
The study observed that using a modified vacuum filtration system assisted in the filtration of large volumes of bacterial cultures, removing the need for centrifuges.
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Quantifying proteins en masse using coulometric mass spectrometry
Coulometric mass spectrometry (CMS) fully quantities proteins without using traditional lab sample testing standards, promising faster vaccine and drug advancement.
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HPLC-MS/MS for NDMA impurity determination in sartans
EPR summarises the development of a HPLC method for the detection, separation and quantification of N-nitrosodimethylamine (NDMA) in both olmesartan API and finished formulations.
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Medicinal cannabis monograph proposed by US Pharmacopeia
A monograph outlining the analytical methods and acceptance criteria for cannabis chemotypes has been released for comment by USP’s Herbal Medicines Compendium.
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API nitrosamines: method sensitivity issues
Here, David Elder discusses the risks presented by active pharmaceutical ingredient nitrosamines and explains how European and US guidance differs on their acceptable levels.
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Blister material as a source of nitrosamine impurities
Study reveals lidding foil with nitrocellulose primer is a potential source of nitrosamine impurities for pharmaceuticals, especially when using plate sealing equipment.
![Photo of affected lot - PROPOFOL Injectable Emulsion, USP (contains benzyl alcohol) 100 mL Single Patient Use, Glass Fliptop Vial. Lot DX9067 [Credit: Pfizer].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Propofol-recall-300x278.jpg)
![Photo of affected lot - PROPOFOL Injectable Emulsion, USP (contains benzyl alcohol) 100 mL Single Patient Use, Glass Fliptop Vial. Lot DX9067 [Credit: Pfizer].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Propofol-recall-e1657792683882.jpg)
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Hospira recalls lot of Propofol Injectable Emulsion
The voluntary US-wide recall of Lot DX9067 of Propofol Injectable Emulsion, USP is due to the possible presence of visible particulate with potentially harmful effects.
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Nitrosamine drug substance-related impurities (NDSRIs)
Dave Elder looks at the guidelines drug manufacturers should follow to reduce nitrosamine impurities, following several recent withdrawals.
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Heparin affinity chromatography promising for extracellular vesicle purification
Researchers find that heparin affinity chromatography (HAC) produces highly pure extracellular vesicles with greater recovery than existing purification methods.
