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Identifying origin of fungi in cleanrooms
Microbiology expert Tim Sandle’s recent video examined identifying the origin of fungi in pharmaceutical cleanrooms.
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Impurities
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Mass spectrometry software can link different data types
A new version of an open-source software is the first tool with an entire data processing pipeline that integrates LC-IMS-MS and MALDI-IMS-MS imaging data.
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NITROSAMINES: Where now?
While determining active intakes and control strategies for short chain alkyl N-nitrosamines was relatively easy to establish, nitrosamine drug substance-related impurities continue to present challenges. Here, Dave Elder reflects on the three main instances of nitrosamine contamination in drug products.
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Collaboration to support quality production of biologics
US Pharmacopeia (USP) and American Type Culture Collection (ATCC) will collaborate to better support the biologics sector in R&D, process development and release of high-quality biologics.
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Developing terminal sterilisation processes for oligonucleotide drugs
A report reviewing the state of sterile oligonucleotide drug processing has recommended ways to aid development of terminal sterilisation processes.
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Peracetic acid-UV light treatment could improve microbial water quality
Researchers have shown a combination of peracetic acid and ultraviolet light could improve microbial water quality in pharmaceutical water systems.
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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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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.
