Subscribe to Newsletter

Overcoming the challenges of nitrosamine impurities in drugs

Why we need to analyze nitrosamine impurities in drugs

Unacceptable levels of nitrosamine impurities were first reported in June 2018 when Valsartan, an angiotensin II receptor blocker containing a tetrazole group, was recalled due to the presence of N-nitrosodimethylamine (NDMA) contamination. Further nitrosamine impurities were subsequently detected in other medications belonging to a group of sartans, including: N-nitrosodiethylamine (NDEA), N-nitrosodiisopropylamine (NDIPA), N-nitrosoethylisopropylamine (NEIPA) and N-nitrosoN-methyl-4-aminobutyric acid (NMBA).1 Nitrosamines are considered a matter of concern as the ICH M7 (R1)2 Guideline classifies them as Class 1 impurities or mutagenic carcinogens and they are categorized as probable carcinogens by the International Agency for Cancer Research (IARC).3

Read the full article now

Log in or register to read this article in full and gain access to The Medicine Maker’s entire content archive. It’s FREE!

Receive content, products, events as well as relevant industry updates from The Medicine Maker and its sponsors.
Stay up to date with our other newsletters and sponsors information, tailored specifically to the fields you are interested in

When you click “Subscribe” we will email you a link, which you must click to verify the email address above and activate your subscription. If you do not receive this email, please contact us at [email protected].
If you wish to unsubscribe, you can update your preferences at any point.

Register to The Medicine Maker

Register to access our FREE online portfolio, request the magazine in print and manage your preferences.

You will benefit from:
  • Unlimited access to ALL articles
  • News, interviews & opinions from leading industry experts
  • Receive print (and PDF) copies of The Medicine Maker magazine