Design News: New Tech Detects Aluminum Impurities in Rare Earth Element Sources
Our FDA Compliance & Enforcement Team reviews how the Food and Drug Administration’s first guidance on nitrosamine impurities shows what the FDA has learned about the sources of such impurities and ...
Pesticide Laundering of Non-Registered Sources, Impurities Profile, Substandard and with No Consistent Quality. Pesticides registration is the process through which EPA examines the ingredients of a ...
In Part I of a three-part article, the authors discuss what constitutes an impurity and the potential sources of impurities in APIs and finished drug products. To ensure the quality of APIs and ...
Medical Design & Outsourcing: FDA warns device manufacturers of nitrosamine impurities that could cause cancer
FDA issued a warning to drug-device combination manufacturers about nitrosamine impurities that could increase the risk of cancer.
Elemental impurities in pharmaceutical products represent a critical area of research, driven by heightened regulatory scrutiny and a growing imperative to ensure patient safety. Such impurities, ...
The European Medicines Agency (EMA) has rolled out its full plan to implement recommendations to reduce the risk that medicines will be contaminated with nitrosamine impurities, identifying short-, ...
Monoclonal antibody (mAb) manufacturers struggling with single-use technology (SUT)-derived impurities should use ultrafiltration and diafiltration as the basis of their removal strategies, according ...
JD Supra: FDA Issues New Guidance on Nitrosamine Impurities in APIs and Drug Products
FDA Issues New Guidance on Nitrosamine Impurities in APIs and Drug Products
Common approaches to analyze elemental impurities for compliance with regulatory requirements are robust but still have some limitations. Elemental impurities present in a drug product are associated ...