Liquid chromatography is an analytical technique utilised widely in the pharmaceutical industry. How does it work and what other methods can it be combined with to enhance its uses?
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The US FDA has announced that all manufacturers should withdraw their ranitidine products from the market due to the risks associated with NDMA impurities.
The FDA has announced that Hikma are now recalling certain lots of Ketorolac Tromethamine injections at the medical facility and retail levels.
Tests conducted by an online pharmacy has revealed high levels of NMDA in the diabetes drug metformin, prompting the company to press for a recall.
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.
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…
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…
Due to a notification of the impurity, liothyronine, exceeding the specification limit, certain batches of levothyroxine 100micrograms/5ml oral solution are being recalled.
Due to cross-contamination with enalapril maleate, Taro is voluntarily recalling one lot of its lamotrigine tablets at the consumer level.
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.
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.
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.