Impurities
Ensuring Product Safety: U.S. FDA Guidance on Testing High-Risk Drug Components for D...
Part two: Industry examining FDA guidance on nitrosamines...
This summer, a wave of regulatory activity on nitrosamines has taken place, with agencies from around the world recently publishing new or revised guidances on nitrosamines.
Vietnam pilot project spotlights the importance of international collaboration to con...
A recently completed pilot project in Vietnam to validate and implement monitoring procedures for nitrosamine impurities in medicines is an inspiring example of how international collaboration and cooperation can help ensure medicines quality across geographies and strengthen the supply chain.
Insights from India: Q&A with USP nitrosamines expert...
The issue of addressing potential nitrosamine impurities in medicines has been the focus at events taking place around the globe in recent months and will continue to do so throughout 2023.
How to Help Avoid Tragedies Linked to Contaminated Cough Syrup...
The World Health Organization (WHO) recently issued a Medical Product Alert after four substandard products were identified in The Gambia, which may be linked to t
Latest nitrosamines recall spotlighting need to control pharmaceutical impurities ...
Revised on: January 17, 2023
Avoid product recalls - Know your impurities
Nitrosamine impurities in medicines: what’s the risk?...
In simple terms, risk is the possibility of something bad happening. It’s the uncertainty around the consequences of an activity with respect to something that we value.