Greater than 95.0% as determined by:
(a) Analysis by RP-HPLC.
(b) Analysis by SDS-PAGE.
Parathyroid Hormone 1-84 (full length) Human Recombinant produced in E.Coli is a single, non-glycosylated, polypeptide chain containing 84 amino acids, having an MW of ~9.4kDa.
The PTH is purified by proprietary chromatographic techniques.
Recombinant human parathyroid hormone (rhPTH 1-84) binds to PTH-1 receptors in the bone and kidney, and indirectly affects calcium reabsorption in the intestines . It increases serum calcium levels by:
rhPTH 1-84 is primarily used as an adjunct to calcium and vitamin D therapy for the control of hypocalcemia in patients with hypoparathyroidism . Hypoparathyroidism is a rare endocrine disorder characterized by insufficient levels of PTH, leading to imbalances in calcium and phosphate levels . This condition can result from surgical removal or damage to the parathyroid glands, autoimmune disorders, genetic mutations, or other factors .
Clinical trials have demonstrated that rhPTH 1-84 is effective in maintaining serum calcium levels while reducing the need for oral calcium and active vitamin D supplementation . However, it carries a black box warning for the potential risk of osteosarcoma, a type of bone cancer . Common adverse reactions include hypocalcemia, hypercalcemia, and hypercalciuria .
rhPTH 1-84 is administered subcutaneously and has been shown to have a generally acceptable tolerability profile . It represents a significant advancement in the management of hypoparathyroidism, offering an effective regimen for patients who cannot be well-controlled on calcium and vitamin D supplementation alone .