Calcifediol Monohydrate CAS 63283-36-3

Calcifediol Monohydrate has been used in some studies to improve vitamin D status. Indications for their use include vitamin D deficiency or insufficiency, refractory rickets (vitamin D resistant rickets), familial hypophosphatemia, hypoparathyroidism, hypocalcemia and renal osteodystrophy and, with calcium, in primary or corticosteroid-induced osteoporosis.

can treat secondary hyperparathyroidism in patients with chronic kidney disease

Items

Specifications

Results

Appearance

Conforms

Conforms

Relative retention: with reference to calcifediol (retention time = about 11 min)

Impurity A = about 1.6(≤0.5%),

Impurity B = about 1.1(≤0.5%)

Impurity C = about1.2(≤0.5%)

Impurity D = about 0.85(≤0.5%)

Single unspecified impurities (≤0.1% MAX)

Total of impurities (≤1.0%)

Not detected

0.03%

Not detected

0.04%

Not detected

0.07%

Calcifediol Monohydrate is transformed in the kidney by 25-hydroxyvitamin D3-1-(alpha)-hydroxylase to calcitriol, the active form of vitamin D3. Calcitriol binds to intracellular receptors that then function as transcription factors to modulate gene expression. Like the receptors for other steroid hormones and thyroid hormones, the vitamin D receptor has hormone-binding and DNA-binding domains. The vitamin D receptor forms a complex with another intracellular receptor, the retinoid-X receptor, and that heterodimer is what binds to DNA. In most cases studied, the effect is to activate transcription, but situations are also known in which vitamin D suppresses transcription. Calcitriol increases the serum calcium concentrations by: increasing GI absorption of phosphorus and calcium, increasing osteoclastic resorption, and increasing distal renal tubular reabsorption of calcium. Calcitriol appears to promote intestinal absorption of calcium through binding to the vitamin D receptor in the mucosal cytoplasm of the intestine. Subsequently, calcium is absorbed through formation of a calcium-binding protein.