It’s good news for pharma companies that the deadline for risk assessment on nitrosamines has been extended to October 1st. However, with the shutdown of many sites due to the COVID-19 pandemic, that could still be a challenge for many.
Is protein binding really so important? And what is plasma protein binding equilibrium dialysis?
A thorough evaluation of each step of the #drugdevelopment process is the only way to be certain you’re free from nitrosamine contamination.
The European Medicines Agency human medicines committee (CHMP) has followed the lead of the US FDA and recommended the suspension of all Ranitidine medicines in the EU due to the low level presence of N-nitrosodimethylamine (NDMA).
The latest requirements of both the FDA and European Medicines Agency Agency set very specific quantifiable limits for Nitrosamine detection. To maintain their role as the leader in this area, QUINTA-ANALYTICA are proud to announce the addition of the Thermo Fisher Scientific Q Exactive™ Focus Hybrid Quadrupole-Orbitrap™ Mass Spectrometer to their already considerable technology line-up.
Are you conducting or planning a clinical trial focusing on the treatment of COVID-19? With decades of experience in BioAnalytical testing, including HPLC/MS/MS, Quinta-Analytica are well placed to support you.
From its origins as a simple straw to today’s superbly-automated piece of modern machinery. The workhorse of laboratories across the world, the pipette, has a deep and wonderful history.
We are happy to announce that our long-term client and trusted partner, Greene Street Pharmaceuticals LLC, strengthened our business relationship today by appointing us as their exclusive API sourcing partner.
Times of crisis overwhelmingly bring out the good in society, however they also see the fakes and counterfitters crawl out from their shadowy world. With huge potential profits to be gained in the relatively short time that people are panicking there really is no better time to be extra cautious across our industry.
The headlines may have faded, but the Nitrosamine contamination saga continues. With all European Medicines Agency Marketing Authorization Holders (MAH) now obligated to evaluate the risks of their products containing chemically synthesized APIs, choosing a partner you can trust has never been more important.