The novel reference markers for fesoterodine fumarate
AssigneeAlembic Pharmaceuticals Limited
InventorsVenkatraman Jayaraman, Sundara Kalyana Balaji, Samir Patel, Thakor Indrajit, Viral Parekh, Mahesh Ladani, Chetan Patil, Ronak Patel, Darshan Parmar
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Abstract
The present invention relates to the new impurities of Fesoterodine, Fesoterodine symmetric dimer impurity and asymmetric dimer impurity, process for preparing and isolating thereof. The invention also deals with analytical standards and analytical methods used for the control of the production process and final quality of Fesoterodine.
Claims20
1-22. (canceled)
A compound of formula II or its salt or its enantiomer.
A process for preparation of the compound of formula II, comprising:
- (a) self condensation of dihydroxy compound (VI), or
- (b) condensation of Fesoterodine base (I) or its salt with dihydroxy compound (VI).
A compound of formula III or its salt or its enantiomer:
A compound of formula V or its salt or its enantiomer.
Dependencies are inferred from the claim text.