USP Method Transfer of Levonorgestrel and Ethinyl Estradiol Tablets from HPLC to UPLC

[ 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,…

FUTURE-PROOF SOLUTIONS FOR REGULATED LABORATORIES IN THE FACE OF CHANGING USP <621> GUIDELINES How to use UPLC technology within “allowable adjustments” to improve QC laboratory throughput For many in the regulatory environment, the collection of standards provided by the United…

USP Method Transfer of Donepezil Tablets from HPLC to UPLC Mia Summers and Kenneth J. Fountain Waters Corporation, 34 Maple St., Milford, MA, USA A P P LI C ATION B ENE F ITS ■■ Updating USP Methods from HPLC…

Transferring Compendial Methods to UPLC Technology for Routine Generic Drug Analysis Kenneth J. Fountain Waters Corporation, Milford, MA, USA Int roduc t ion Manufacturers of generic drugs must be able to prove that the compounds they produce are comparable to…