Impurities
Revisiting the Landscape of Potential Nitrosamines in Pharmaceuticals using CPCA fram...
FDA's Draft Guidance for Topical Ophthalmic Drug Products: USP Standards ...
This year has seen a flurry of activity by the U.S. Food and Drug Administration surrounding ophthalmic products.
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.
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.
USP’s Preferential Access for Regulators (PAR) Program: Supporting the Global Supply ...
In the U.S. and around the world, quality standards developed by the U.S. Pharmacopeia (USP) support the availability of safe, quality medicines, regulatory efficiencies, and a strong global medicine supply chain.
Nitrosamine Impurities: Latest USP Tool Further Aids Understanding and Control...
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.
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