In our final installment of the nitrosamine podcast series, Dr. Teasdale concludes the topic discussing future regulatory guidance relative to nitrosamines and other mutagenic impurities.
Method Lifecycle Management Library
Demonstration of the highly sensitive and robust LC-MS/MS quantification for six nitrosamine impurities in solutions containing sartans and ranitidine drug substances.
Learn how to achieve the data quality and integrity necessary to drive correct decisions about pharmaceutical product safety and efficacy.
In part two of The Nitrosamine Crisis, Dr. Teasdale talks about the challenges in nitrosamine testing and provides advice on facilitating accurate quantitation.
In part one of a 3-part series on the Nitrosamine crisis, Dr. Andrew Teasdale of AstraZeneca discusses regulatory expectations, reporting requirements, and minimizing risk relative to solvent contamination.