11 DESCRIPTION
Doxercalciferol is a synthetic vitamin D2 analog. Doxercalciferol undergoes metabolic activation in vivo to form 1α,25-dihydroxyvitamin D2 (1α,25-(OH)2D2), a naturally occurring, biologically active form of vitamin D2.
Doxercalciferol is a colorless crystalline compound with a calculated molecular weight of 412.65 and a molecular formula of C28H44O2. It is soluble in oils and organic solvents, but is relatively insoluble in water. Chemically, doxercalciferol is (1α,3β,5Z,7E,22E)-9,10-secoergosta-5,7,10(19),22-tetraene-1,3-diol. The structural formula is:
Doxercalciferol Injection is a sterile, clear, and colorless solution.
The 2 mL multiple-dose vials contain 4 mcg/2 mL (2 mcg/mL) of doxercalciferol. Each milliliter (mL) of solution contains 2 mcg doxercalciferol and the following inactive ingredients: ethanol, 96% (0.078 mL); polysorbate 20 (10 mg); sodium chloride (1.5 mg); butylated hydroxytoluene (0.02 mg); sodium phosphate dibasic, heptahydrate (14.4 mg); sodium phosphate monobasic, monohydrate (1.8 mg); and disodium edetate (1.1 mg).
The 5 mL multiple-dose vials contain 10 mcg/5 mL (2 mcg/mL) of doxercalciferol. Each milliliter (mL) of solution contains 2 mcg doxercalciferol and the following inactive ingredients: ethanol, 96% (0.078 mL); polysorbate 20 (10 mg); sodium chloride (1.5 mg); butylated hydroxytoluene (0.02 mg); sodium phosphate dibasic, heptahydrate (14.4 mg); sodium phosphate monobasic, monohydrate (1.8 mg); and disodium edetate (1.1 mg).