Patent ID: 11926583
Assignee: EIRGEN PHARMA LTD.
Field: Pharmaceuticals (Chemistry)
Classification: CPC C  A | IPC A  C

Claim 12:
13. A stabilized 1,25-dihydroxyvitamin D2 composition, characterized by:
(a) being free of formate ester solvents;
(b) having no more than 0.5% total residual solvents by weight;
(c) comprising one or more of 1β,25-dihydroxyvitamin D2, 5,6-trans-1,25-dihydroxyvitamin D2, 1,25-dihydroxyprevitamin D2, and 22-cis-1,25-dihydroxyvitamin D2 present in a total amount up to 0.5%, based on total area under the curve (“AUC”) by a high performance liquid chromatography (“HPLC”) assay; and
(d) comprising an initial amount of 1,25-dihydroxyvitamin D2 as manufactured and a second amount of the 1,25-dihydroxyvitamin D2 after the composition is stored at −20° C. under argon for a period of 12 months, wherein the initial and second amounts each are in a range of 98.5-100% purity based on AUC by HPLC assay, and the second amount is 99.5-100% of the initial amount.