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Impurities
news
Mylan announces voluntary recall of Alprazolam tablets
Due to possible contamination from a foreign substance, Mylan Pharmaceuticals is voluntarily recalling one batch of its Alprazolam tablets.
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MHRA announces recall of Perrigo ranitidine products
The UK healthcare agency has issued an alert for Perrigo ranitidine products, recalling and quarantining certain batches.
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European Pharmaceutical Review Issue 5 2019
Within this issue is an analysis of the impacts that low temperature can have on protein aggregation, a discussion on maintaining the safety and quality of medicines when delivered using drones and an exploration of chromatographic techniques used to identify impurities in radiopharmaceuticals. Other articles focus on regulatory non-compliance, excipients…
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FDA announces update to NDMA testing recommendations
The FDA has released an additional NDMA testing method and has alerted the public to multiple voluntary recalls of ranitidine.
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Mutagenic impurities – a JPAG event
The Joint Pharmaceutical Analysis Group held an event in London, discussing the testing of nitrosamine mutagenic impurities in pharmaceutical products and the next steps for manufacturers to take.
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Sanofi announces voluntary recall of Zantac products
The pharmaceutical company Sanofi is voluntarily recalling its OTC Zantac products in the US and Canada due possible contamination with NDMA.
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FDA issues warning letter to Torrent Pharmaceuticals
Torrent Pharmaceuticals has received a warning letter from the FDA for violating cGMP regulations at its manufacturing facility in India.
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MHRA announces recall of Zantac products made by GSK
The UK MHRA has issued an alert for the recall of unexpired Zantac products made by GSK due to the possible contamination of ranitidine in the medicines.
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FDA recommends LC-HRMS to test for NDMA in ranitidine products
The FDA recommends drug manufacturers to use LC-HRMS to test for NDMA in ranitidine products, as high temperatures generate the impurity.
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EMA releases guidance to companies on avoiding nitrosamines in drugs
The European Medicines Agency has issued advice to pharmaceutical companies on how to avoid the presence of nitrosamines in medicines.
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Sandoz voluntarily recalls ranitidine over NDMA contamination concerns
The probable carcinogen N-nitrosodimethylamine was detected in Sandoz’s ranitidine capsules, prompting the voluntary move.
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Losartan drug recall expanded to include five more lots
FDA announces the voluntary recall for the losartan medications has been extended to include more lots, after impurities were found in the drugs.
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EMA to provide guidance on avoiding nitrosamines in medicines
The EMA has announced it is drafting guidance on how to avoid the presence of nitrosamines, a probable carcinogenic ingredient, in drugs.
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NDMA discovered in samples of ranitidine medicines
The EMA and the FDA are investigating some ranitidine medicines after they were found to contain NDMA, a probable human carcinogen.
