Identification and Characterization of an Isolated Impurity Fraction: Analysis of an Unknown Degradant Found in Quetiapine Fumarate

A Workflow Approach for the Identification and Structural Elucidation of Impurities of Quetiapine Hemifumarate Drug Substance Michael D. Jones, Marian Twohig, Karen Haas, and Robert S. Plumb Waters Corporation, Milford, MA, USA INT RODUC T ION The ability to understand…

[ APPLICATION NOTEBOOK ] IMPURITIES Developing Safe and Effective Drugs INT RODUCTION NAVIGATION T he pharmaceutical industry is integral in maintaining public health by providing therapeutic and preventative medicines. T he cornerstones of bringing new medicines to market are quality,…

Application Note Routine Accurate Mass Measurement for the Identification of Impurities in Quetiapine Fumarate API Using the SmartMS-Enabled ACQUITY RDa Detector Tirupateswara Rao. B, Dilshad Pullancheri, Bheeshmacharyulu S, Dr. Padmakar Wagh Waters Corporation Abstract This application note demonstrates a simplified…

Extractables, Leachables, and Food Contact Materials Application Notebook Extractables, Leachables, and Food Contact Materials Testing The safety of pharmaceuticals, cosmetics, and foodstuffs may be compromised by chemical compounds in the various types of packaging and food contact materials (FCMs) that…