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.
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