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US 12,422,415 B2Granted
Analytical methods of assessing cytisine purity
AssigneeAchieve Life Sciences, Inc.
InventorsCurtis Swift, Katie Williams, Nigel Richardson, Marco Delgado
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Abstract
Methods of assessing purity of cytisine using gradient chromatography at multiple wavelengths is provided herein.
Claims17
A chromatographic method of assessing purity of cytisine, the method comprising:
- (a) introducing a cytisine sample to a column comprising a stationary phase including stearic acid and having a length of 150 mm, an inner diameter of 4.6 mm, and a particle size of 2.5 μm, wherein the cytisine sample comprises one or more impurities;
- (b) applying a first mobile phase having a pH of about 10 to the column such that cytisine and the one or more impurities are retained on said column;
- (c) eluting cytisine and the one or more impurities by applying a second mobile phase having a pH of about 10 to said column;
- and
- (d) detecting cytisine and the one or more impurities in the second mobile phase.
2 more elements
Dependencies are inferred from the claim text.