|
- Nitrosamine - Wikipedia
There have been recalls for various medications due to the presence of nitrosamine impurities There have been recalls for angiotensin II receptor blockers, ranitidine, valsartan, duloxetine, and others
- Information about Nitrosamine Impurities in Medications | FDA
FDA has been investigating the presence of impurities, called nitrosamines, in some types of medications Nitrosamines are common in water and foods, including cured and grilled meats, dairy
- What Are N-Nitrosamines and Should You Be Concerned?
Uncover N-nitrosamines, ubiquitous compounds impacting daily life Gain essential insights into their nature and how to approach their presence with confidence
- What Are Nitrosamines, and What Are Nitrosamine Impurities . . . - GoodRx
A nitrosamine contains one oxygen block (“O”) and two nitrogen blocks (“N”) These attach to two other blocks (“R”) that are unique to each type of nitrosamine
- An Organic Chemist’s Guide to N-Nitrosamines: Their Structure . . .
N -Nitrosamines are a class of compounds notorious both for the potent carcinogenicity of many of its members and for their widespread occurrence throughout the human environment, from air and water to our diets and drugs
- Pharmaceutical Nitrosamines: A Comprehensive Review of Health Risks . . .
Nitrosamines, identified as unexpected impurities in several drug substances and drug products, have raised significant concern due to their mutagenic and carcinogenic properties Extensive research has shown that a majority of nitrosamines are potent carcinogens, affecting various organs in multiple species This article comprehensively analyzes pharmaceutical nitrosamine impurities, their
- Nitrosamine impurities | European Medicines Agency (EMA)
The European Medicines Agency (EMA) has assessed the risk of nitrosamine formation or presence during the manufacture of human medicines and has provided guidance to marketing authorisation holders to avoid the presence of nitrosamine impurities
- FDA Softens August 2025 NDSRI Deadline—Progress Reports Now Accepted
Recently, FDA announced a deadline shift, although the Agency did so quietly On June 23, 2025, FDA updated its CDER Nitrosamine Impurity Acceptable Intake Limits webpage to permit manufacturers and sponsors more time to submit required changes for nitrosamine drug substance‑related impurities (NDSRIs) for approved or currently marketed products The Agency confirmed that it will now accept
|
|
|