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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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Impurities
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Regulating heavy metals in cannabis: what can be learned from the pharmaceutical industry?
The ever-increasing demand for cannabis-based products requires US state regulators to set guidelines that ensure products are safe for human use. However, as medicinal cannabis moves forward at a rapidly increasing pace, regulations are falling behind. Here, Robert Thomas discusses the many inconsistencies across US states for monitoring levels of…
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The role of ELSIE in evolving current thinking on extractables and leachables
Extractables and Leachables Safety Information Exchange (ELSIE) has been the most influential industry group in developing guidelines for extractables and leachables. In the wake of the ICH convening a new group to develop a concept paper and business plan on their Q3E Impurity Guideline, Dave Elder discusses the strides that…
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Specific batches of levothyroxine recalled as precautionary measure
Due to a notification of the impurity, liothyronine, exceeding the specification limit, certain batches of levothyroxine 100micrograms/5ml oral solution are being recalled.
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Taro Pharmaceuticals voluntarily recalls one lot of lamotrigine tablets
Due to cross-contamination with enalapril maleate, Taro is voluntarily recalling one lot of its lamotrigine tablets at the consumer level.
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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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Genotoxic impurities in pharmaceutical products
Several organisations have developed guidelines that specifically address genotoxic impurities in pharmaceutical products. Here, Dr Sol Bobst and Gowri Sukumar discuss the regulatory landscape, testing requirements and calculation methods for occupational exposure limits.
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QA/QC & Analytical Techniques In-Depth Focus 2019
This in-depth focus includes features that examine how microbiologists can advance their methods of study, discuss the regulatory guidelines regarding genotoxic impurities and explore Raman spectroscopy as a non-invasive analysis technique.
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EMA update: non-EU metformin medicines contain acceptable levels of NDMA
The EMA has announced that metformin tablets from outside the EU do not contain unacceptable levels of NDMA impurities and EU metformin is not affected.
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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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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.
whitepaper
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.
