Express Pharma
Home  »  Downloads  »  Be Agilent Sure for Mutagenic Impurities

Be Agilent Sure for Mutagenic Impurities

Analytical Solutions to Answer Regulatory Requirements

0 70
Read Article

Solutions for Emerging Nitrosamine Contamination of Pharmaceuticals

Nitrosamines are chemical compounds classified as probable human carcinogens on the basis of animal studies.  Since 2018, an increasing number of nitrosamine impurities, including N-nitrosodimethylamine (NDMA), were found in a chemically related group of antihypertensive drugs known as ‘sartans’. Subsequently, a nitrosamine impurity was detected in batches of ranitidine, a medicine used to treat heartburn and stomach ulcers and chemically unrelated to sartans. And Metformin is under the same alert now.

This led to some product recalls and to an EMA review under article 5(3) of Regulation (EC) No 726/2004 to provide guidance to marketing authorization holders on how to avoid the presence of nitrosamine impurities in human medicines. As part of this review, the CHMP has requested marketing authorization holders for human medicines containing chemically synthesized active substances to review their medicines for the possible presence of nitrosamines and test all products at risk.

Fill the form below and download our latest literature on Genotoxic Impurities Analysis

    This is co-hosted by Express Pharma and Agilent

    By submitting this form, you are confirming you are an adult 18 years or older and agree to Express Pharma contacting you with marketing-related emails or by telephone. You may unsubscribe from receiving such communications from Express Pharma at any time. Express Pharma web sites and communications are subject to our Privacy Notice and Terms of Use.

    Yes, I would like to receive email updates about Agilent products, services and events.
    For full details of how we will treat your information please view our privacy policy: www.agilent.com/home/privacy-policy

    Leave A Reply

    Your email address will not be published.

     Introducing Smart Autoinjector: Changing the paradigm of usability, cost & size
    Know More?
    close-image