Ursodoxicoltaurine Dihydrate and its Impurities

Ursodoxicoltaurine Dihydrate, also known as ursodiol, is a secondary bile acid, produced in humans and most other species from metabolism by intestinal bacteria. Reference standards of Ursodoxicoltaurine Dihydrate API, and its pharmacopeial, non pharmacopeial impurities, and stable isotopes are listed below.