Product descriptionParicalcitol was launched as Zemplar in the US for the prevention and treatment of secondary hyperthyroidism associated with chronic renal failure. Paricalcitol is a synthetic vitamin D2, namely a novel 1-alpha-hydroxy-19-noranalogue in which the ring A exocyclic methylene group, typical of all vitamin D systems, has been replaced by two hydrogen atoms. Paricalcitol is the first vitamin D analogue marketed for this indication. In patients with chronic renal failure, Paricalcitol appreciably reduced levels of parathyroid hormone (PTH) without a significant difference in the incidence rate for hypercalcemia or hyperphosphatemia when compared with placebo.
ApplicationParicalcitol is a synthetic 1,25-dihydroxy vitamin D2 analog. As vitamin D deficiency, associated with chronic kidney disease, leads to an increase in parathyroid hormone (secondary hyperparathyroidism), paricalcitol is used in renal patients to block parathyroid hormone overproduction. Vitamin D deficiency is also a risk factor in cancer, cardiovascular disease, hypertension, and diabetes, and paricalcitol may have applications in those contexts as well.
It is used for the prevention and treatment of SHPT, and the prevention and treatment of SHPT in patients with stage III and IV chronic kidney disease (CKD) before dialysis and transplantation.
Package1g/2g/5g/10g bag/bottle
SpecificationITEMS | SPECIFICTIONS |
APPEARANCE | White to off-white powder |
IDENTIFICATION | HPLC |
| IR |
Specific rotation | +108.0°~ +114.0° |
Clearance for solution | Clear |
Color of solution | No color |
Related substance | Z4a NMT 0.10% |
| Single impurity NMT 0.10% |
| Total Impurity NMT 0.5% |
Loss on drying | NMT 2.0% |
Endotoxin | NMT 10000EU/mg |
Residue solvents | Isopropyl acetate NMT 0.5% |
| Isopropyl Alcohol NMT 0.5% |
Assay | Based on dry basis 97.0% ~ 103.0% |