US 11,926,583 B2
Stabilized 1, 25-dihydroxyvitamin D2 and method of making same
Uttam Saha, Thornhill (CA)
Assigned to EIRGEN PHARMA LTD., Waterford (IE)
Filed by CYTOCHROMA INC., Markham (CA)
Filed on Jan. 2, 2014, as Appl. No. 14/146,397.
Application 14/146,397 is a continuation of application No. 12/403,271, filed on Mar. 12, 2009, abandoned.
Claims priority of provisional application 61/036,021, filed on Mar. 12, 2008.
Prior Publication US 2014/0113886 A1, Apr. 24, 2014
Int. Cl. C07C 401/00 (2006.01); A61K 31/592 (2006.01); A61K 45/06 (2006.01)
CPC C07C 401/00 (2013.01) [A61K 31/592 (2013.01); A61K 45/06 (2013.01)] 19 Claims
 
1. A stabilized, crystalline 1,25-dihydroxyvitamin D2 composition, characterized by:
(a) being free of formate ester solvents;
(b) comprising no more than 0.5% by weight of total residual solvents; and
(c) wherein an initial purity of the composition is in a range of 98-100% as manufactured and a second purity is in a range of 98-100% after the composition is stored at 60° C. for a period of 24 hours, and wherein both the initial and the second purities are based on total area under the curve (“AUC”) by a high performance liquid chromatography (“HPLC”) assay.