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Nitrosamines analysis with LC/MS-MS
This ebook provides a comprehensive overview of nitrosamine analysis for the pharmaceutical industry.
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ranitidine
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Advancing nitrosamines analysis with gas chromatography
Researchers suggest full evaporation static headspace gas chromatography (FE-SHSGC) could be a universal method for the analysis of semi-volatile nitrosamines in pharmaceutical products.
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Future proofing risk assessment: preventing the next nitrosamine incident
The valsartan nitrosamine contamination issue was probably the most significant quality issue to hit the pharmaceutical industry in a decade. Here, Dave Elder outlines how agencies and manufacturers are dealing with the problem and indicates the knowledge gaps that might be concealing future complications.
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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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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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EMA recommends eight drugs for approval from April meeting
The EMA's human medicines committee has adopted a positive opinion for eight medicines, recommending their marketing authorisation.
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EMA announces update on nitrosamine impurities in medicines
The EMA has released an update on nitrosamines in drugs, saying that work is continuing to prevent and manage these impurities.
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American Health Packaging voluntarily recalls ranitidine tablets
Ranitidine tablets have been recalled due to the possibility of the products containing unacceptable levels of NDMA.
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Medreich ranitidine tablets recalled due to possible NDMA contamination
Medreich Plc is recalling a number of ranitidine products due to possible contamination with an impurity N-nitrosodimethylamine (NDMA).
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FDA announces one nizatidine and two ranitidine voluntary recalls
Mylan, Appco Pharma and Denton Pharma are voluntarily recalling nizatidine and ranitidine products due to potential unacceptable levels of NDMA.
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MHRA announces recall of Medley Pharma ranitidine tablets
The UK MHRA has issued a recall of two ranitidine products from Medley Pharma as a precautionary measure due to possible contamination.
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EPR’s news round-up 2019: the stories that defined the year
This article highlights the 10 most popular news stories published by European Pharmaceutical Review in 2019.
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FDA update: additional testing of ranitidine and nizatidine ordered
To further its investigation into the cause of the NDMA impurities found in ranitidine and nizatidine, the FDA has asked manufacturers of these products to expand their testing to include all lots of the medication.
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MHRA announces recall of 13 over-the-counter ranitidine medicines
Four companies are recalling batches of certain over-the-counter ranitidine medicines used to treat conditions such as stomach ulcers and heartburn.
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Precision Dose voluntarily recalls ranitidine oral solution
The FDA has announced that Precision Dose Inc is voluntarily recalling five lots of its ranitidine oral solution in the US.
