Contamination from ethylene glycol and diethylene glycol in liquid formulation poses a high risk to patient safety. Throughout recent years there have been multiple fatalities reported due to the presence of these contaminants in drug products. This whitepaper covers the...
Container closure integrity, which is verified by container closure integrity testing (CCIT), is critical to ensure the sterility of drug products. Physical, chemical, and biological assessments must be carried out to make sure components are compatible and fit for use....
In this article published in Pharmaceutical Technology, Susan Schniepp and Shiri Hechter explain how an analytical method to be used for routine testing but not published in a pharmacopeia can be validated. Read Full Story