Nitrosamines Risk Assessments for BASF’s pharmaceutical excipients

Nitrosamines Risk Assessments for BASF’s pharmaceutical excipients are now available for instant download in RegXcellence™! These statements enable you to better understand potential risk for Nitrosamine formation and presence.

What are nitrosamines?

Spray drying Eudragit® E-PO with acetaminophen using 2- and 3-fluid nozzles for taste masking

Fabrication and evaluation of stable amorphous polymer-drug composite particles via a nozzle-free ultrasonic nebulizer

Fine excipient materials in carrier-based dry powder inhalation formulations: The interplay of particle size and concentration effects

Nitrosamines are chemical compounds that can be formed from secondary amines with a nitrosating agent. Those nitrosating agents can be nitrous acid, nitrites or NOX. Nitrosamines may be found in drinking water and foods. The International Agency for Research on Cancer (IARC) has classified these compounds as carcinogens. Recently, international agencies haves been investigating the presence of nitrosamine impurities in various commercial drugs, particularly those with a highrisk API (e.g. Metformin) or where certain solvents/reagents are used in the API
synthesis under specific reaction conditions (e.g. Valsartan).

You can access these documents online 24/7 through RegXcellence™. Go to https://www.pharmaexcipients.com/basf/regxcellence-your-virtual-quality-regulatory-assistant/ to sign up or login!

excipients formulation