In this app note you will learn how to develop a highly specific, sensitive, and reproducible method for the quantitation of N-nitroso dabigatran etexilate impurity in dabigatran etexilate mesylate drug substance using an Agilent 6495C triple quadrupole LC/MS (LC/TQ) coupled to an Agilent 1290 Infinity II LC.
Trends, Best Practices, and Analytical Challenges in Chemical Characterization of Medical Devices
October 7th 2024Chemical characterization of medical devices, including drug-device combination products, is crucial for ensuring regulatory compliance and patient safety by identifying and quantifying chemicals that may interact with the human body. This paper explores current trends, best practices, and regulatory developments in extractables and leachables (E&L) testing for medical devices.
Pick Your Poison: Isolation of Paclitaxel (Octt 2024)
October 4th 2024The diterpenoid, paclitaxel, which was identified as a potent chemotherapy agent for breast and ovarian cancer originates from the Pacific Yew tree. The isolation of paclitaxel from its major impurities is shown with the use of Hamilton’s PRP-1 (5 µm) HPLC column.