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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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.
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.
The EMA's human medicines committee has adopted a positive opinion for eight medicines, recommending their marketing authorisation.
The EMA has released an update on nitrosamines in drugs, saying that work is continuing to prevent and manage these impurities.
Ranitidine tablets have been recalled due to the possibility of the products containing unacceptable levels of NDMA.
Medreich Plc is recalling a number of ranitidine products due to possible contamination with an impurity N-nitrosodimethylamine (NDMA).
Mylan, Appco Pharma and Denton Pharma are voluntarily recalling nizatidine and ranitidine products due to potential unacceptable levels of NDMA.
The UK MHRA has issued a recall of two ranitidine products from Medley Pharma as a precautionary measure due to possible contamination.
This article highlights the 10 most popular news stories published by European Pharmaceutical Review in 2019.
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.
Four companies are recalling batches of certain over-the-counter ranitidine medicines used to treat conditions such as stomach ulcers and heartburn.
The FDA has announced that Precision Dose Inc is voluntarily recalling five lots of its ranitidine oral solution in the US.
Aurobindo has recalled prescription and over-the-counter ranitidine due to the medications containing unacceptable levels of NDMA.