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Statement from the FDA on NDMA found in drugs outside the US
The FDA has released a statement on the investigations into the presence of nitrosamines in some drugs; highlighting that there are currently no recalls of metformin within the US.
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Impurities
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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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Application note: Determining the structure of impurities
Most, if not all pharmaceutical companies will have experienced a product, that has been on the market for a long time, to suddenly and unexpectedly trigger a signal for an unknown substance in the quality control (QC) laboratory approval process.
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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.
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Tc-99m radiopharmaceuticals and in-house chromatographic methods
Technetium-99m (99mTc) is a synthetic radioisotope that is used worldwide to produce radiopharmaceuticals that are mainly used for diagnostic purposes in nuclear medicines. The purity of the final radiopharmaceutical (99mTc-R) can be confirmed by applying chromatographic methods. This method is based on different rates of movement of substances in a…
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Paracetamol tablets recalled due to potential fungal contamination
Specific batches of paracetamol tablets are being recalled as some pots have been found to contain discoloured tablets due to fungal contamination.
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FDA releases statement on ranitidine testing results
The FDA has issued a statement on the results from ranitidine medication testing for nitrosamines, saying that they contain no more NDMA than smoked meats.
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Scientific poster: Time for science – Don’t let your time evaporate
Get some hints on how you can optimize the most time-demanding steps in your lab.
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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.
