// November 11, 2022
Latest nitrosamines recall spotlighting need to control pharmaceutical impurities ...
Revised on: January 17, 2023
Impurities
// March 07, 2023
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.
// December 05, 2022
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
// June 22, 2022
Avoid product recalls - Know your impurities
Impurities are any components that are not active ingredients or excipients, and that can compromise quality in a drug substance or product. Pharmaceutical impurities can be classified as organic or inorganic and include residual solvents. The presence of impurities results from manufacturing and degradation processes.
// March 12, 2021
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.
// May 06, 2015
Elemental Impurities – Their Impact on Drug Quality...
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.
// July 08, 2014
Shedding Light on Impurities in Medicines
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.