Usage of highly accurate analytical solutions can help pharma firms design impurity-free medicines.
Today, there are a number of medicines that are used to fight hypertension. However, global authorities have been clamping down on sales of some of these drugs because these are suspected to be carrying impurities. Usage of highly accurate analytical technology can change this scenario and help pharmaceutical companies design impurity-free drugs.
Angiotensin-receptor blockers (ARBs), also known as sartans, are among the most widely used medicines for hypertension and heart failure. In July 2018 the US Food and Drug Administration (FDA) issued a warning to over 40 major drug makers, majority of whom were from India. Global authorities have been clamping down on sales of some blood pressure medicines as they are suspected to be tainted with two probable carcinogens – N-nitrosodiethylamine (NDEA) and N-nitrosodimethylamine (NDMA). The FDA has released testing methods to provide options for regulators and industry to detect nitrosamine impurities in ARB drug substances and drug products.
For over a decade, Thermo Fisher Scientific has been providing advanced technologies and research capabilities to researchers and professionals across the globe. “Being one of the leading manufacturers for chromatography and mass spectrometry instruments, we have optimised and validated methods on our Thermo Scientific Gas Chromatography-Mass Spectrometry (GC-MS) GCMS and Liquid Chromatography and Mass Spectrometry LCMS systems. As the pharmaceutical industry is continually evolving, our products are helping customers not just meet all sensitivity and repeatability requirements of current regulations but also exceed the requirements to meet more stringent control limits expected in future”, said Amit Chopra, managing director, India and Middle East, Thermo Fisher Scientific.
It’s a formidable task for even the most experienced pharmaceutical professionals to test every batch of sartans for impurities. However, with the right equipment, the tasks become more manageable. A configuration combining the headspace and the liquid injections on the same gas chromatography offers the sensitivity, flexibility and the required productivity for quality control testing laboratories. NDMA and NDEA were the initial impurities found in different angiotensin receptor blocker (ARB) class of drugs. However, the list of nitrosamine impurities monitored is growing steadily.
European Medicines Agency has offered pharma companies a two-year grace period to adjust their standards and eliminate impurities within production. Pharmaceutical companies now need to work quickly on the new standards and place strict limits on impurity levels post this transition period to demonstrate that their sartan products have no quantifiable levels of nitrosamines.
“At Thermo Fisher our mission, is to enable our customers to make the world healthier, cleaner and safer, which gives our work a higher purpose.” said Chopra.