Latest nitrosamines recall spotlighting need to control pharmaceutical impurities ...
Revised on: January 17, 2023
USP has launched the newest tool in our suite of solutions to address the evolving nitrosamines crisis: the Nitrosamines Analytical Hub, a public, web-based repository of downloadable analytical procedures to test for nitrosamine impurities and related substances in pharmaceuticals.
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
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.
Today, approximately 80% of all active pharmaceutical ingredients in medicines sold in the U.S. are manufactured in another part of the world. While manufacturers have to ensure the quality and consistency of ingredients that go into final pharmaceutical products, they must also employ measures for the proper control of unwanted impurities in drugs and drug ingredients.
What are medicine impurities and from where do they come? Identifying and describing impurities is a critical safety issue concerning manufacturers, regulators, and patients. This post describes the types of impurities found in medicines and how they may impact drug quality.