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Metformin oral solution recalled due to nitrosamine impurity
A Class 2 recall notice for one batch of Rosemont Pharmaceuticals metformin hydrochloride 500mg/5ml oral solution has been issued by the MHRA.
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Impurities
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Review: Good identification practices for organic extractables and leachables via mass spectrometry
The function of a pharmaceutical drug product or a medical device is to provide the patient with a desired therapeutic benefit.
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Nitrosamines: the latest position
Timelines for assessing the potential for contamination of medicinal compounds with nitrosamines have been revised. Here, Dave Elder explains the EMA’s and FDA’s positions and the likely scenarios to be encountered.
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Nelson Labs: supporting internal quality processes
Nelson Labs is the leading global extractables and leachables lab testing platform, in this guide find out about their other services and how, from development to delivery, they can help get your products to market.
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European Pharmacopoeia adopts a new chapter for the analysis of N-nitrosamine impurities
The new general chapter (2.5.42) outlines three procedures for the analysis of N-nitrosamine impurities in active substances.
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CHMP recommends five medicines for approval in latest meeting
The European Medicines Agency committee reports its November findings, including five drugs recommended for marketing authorisation.
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NDMA: a recall trigger for the drug development industry
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.
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QA/QC & Analytical Techniques In-Depth Focus 2020
Included in this in-depth focus is a discussion on how to detect and eliminate NDMA impurities in medicines and an article exploring the complexities of sterility assurance, providing manufacturers with guidance.
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European Pharmaceutical Review Issue 4 2020
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…
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EMA issues opinion on nitrosamines in medicines
The agency’s opinion will require companies to take measures to reduce nitrosamine impurities in medicines and carry out and action the results of risk assessments.
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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.
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EMA issues guidance on medicine impurities, in light of nitrosamine detection
After nitrosamines were detected in sartan medicines, the EMA has released new recommendations about handling and reporting impurities in drugs.
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Application Notes & Whitepapers 2020
The latest applications and advice from industry experts.
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Amneal recalls Metformin Hydrochloride Extended Release Tablets to consumer level
The voluntary recall of Metformin Hydrochloride Extended Release Tablets, 500mg and 750mg is due to unacceptable levels of NDMA impurities.
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Preventing contamination during biopharmaceutical production
A study that analysed QA/QC incidents at several biomanufacturing plants has revealed how companies can best hope to detect and mitigate virus contamination.
