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US 2010/0062046 A1Published application
Polymorphs of nicotinic intermediates
OwnerDouglas J.M. Allen, Travis L. Houston +3inventors
InventorsDouglas J.M. Allen, Travis L. Houston, Lien H. Koztecki, Melissa J. Casteel, David Burns Damon
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Abstract
Crystalline forms of compounds (II), (III) and (IV) and processes to produce them are provided.
Claims15
Substantially pure varenicline free base Form C suitable for administration to a human subject comprising
- a) less than 2% by weight of a first impurity N-formylvarenicline, relative to the total weight of varenicline, and
- b) less than 2% by weight of a second impurity N-carboxyvarenicline adduct, relative to the total weight of varenicline,
- wherein Form C is characterized by a powder x-ray diffraction pattern obtained using CuK α radiation which includes peaks at 2θ (degrees) 11.3, 17.3, 19.8, 20.6, and 22.0±0.2.
Substantially pure varenicline free base Form C suitable for administration to a human subject comprising
- a) less than 2% by weight of a first impurity N-formylvarenicline, relative to the total weight of varenicline, and
- b) less than 2% by weight of a second impurity N-carboxyvarenicline adduct, relative to the total weight of varenicline,
- wherein Form C is characterized by a 13C proton decoupled cross-polarization magic angle
- spinning (CPMAS) solid state NMR spectra which includes peaks at 149.8, 144.6, 143.9, 122.9, 50.8, and 42.5±0.2 ppm referenced to an external sample of solid phase adamantane at 29.5 ppm.
1 more element
Dependencies are inferred from the claim text.