The new general chapter (2.5.42) outlines three procedures for the analysis of N-nitrosamine impurities in active substances.
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The European Medicines Agency committee reports its November findings, including five drugs recommended for marketing authorisation.
Product recalls due to contamination issues can be extremely costly for companies, in addition to the associated health implications. In this article, Marc Baiget Francesch explores the potential risks associated with N-nitrosodimethylamine (NDMA) contamination, why is it such a frequent contaminant and how to detect and eliminate the risks.
Within this issue find articles on the complexities of sterility assurance, how to detect and eliminate the risk of NDMA contamination and the findings from a study involving a novel formulation of cannabinoids that has been developed to treat glioblastoma. Also included are articles on the opportunities blockchain provides for…
Application note: Impurity analysis in pharmaceutical products with the advanced photodiode array detector SPD-M40
The accurate determination of trace impurities is of great importance in both pharmaceutical drug development and drug manufacturing. This application note showcases the new photodiode array detector SPD-M40, which measures the concentration of impurities in pharmaceutical products.
After nitrosamines were detected in sartan medicines, the EMA has released new recommendations about handling and reporting impurities in drugs.
Pharmaceutical process development involves multi-disciplinary groups of chemists and analysts whose goal it is to create the API by the cheapest, most efficient route while ensuring product safety through effective impurity control measures.
The voluntary recall of Metformin Hydrochloride Extended Release Tablets, 500mg and 750mg is due to unacceptable levels of NDMA impurities.
A study that analysed QA/QC incidents at several biomanufacturing plants has revealed how companies can best hope to detect and mitigate virus contamination.
Lonza and Sanquin partner for commercialisation of specialised MAT reagents for accurate and reliable in vitro pyrogen testing
Lonza Sales AG, through its Bioscience Division has joined forces with Sanquin Reagents B.V. to enable drug developers and quality control laboratories to take full advantage of the power of the Monocyte Activation Test (MAT).
The US FDA has announced ICU Medical is recalling a lot of Lactated Ringer's Injection due to iron oxide particulates being found by a consumer.
Researchers have used CRISPR-Cas to edit the genes of contaminating proteins in mammalian cells used to produce recombinant-protein drugs, which could reduce costs and strengthen quality.