Iptacopan Hydrochloride Monohydrate and its Impurities

Iptacopan Hydrochloride Monohydrate, marketed under the brand name Fabhalta, is a novel oral medication classified as a complement factor B inhibitor. It is primarily used to treat rare blood and kidney disorders. Reference standards of Iptacopan Hydrochloride Monohydrate API, and its pharmacopeial, non pharmacopeial impurities, and stable isotopes are listed below.