Calcitriol (1,25‑dihydroxyvitamin D₃) is the biologically active form of vitamin D, playing a key role in regulating calcium and phosphate metabolism in the human body. Among its essential functions are the facilitation of calcium absorption, the maintenance of bone health, and the support of numerous physiological systems. Owing to these properties, calcitriol is used in the manufacture of medicinal products for the treatment of conditions such as osteoporosis, disorders of bone mineralization, hyperparathyroidism and renal failure.
Calcitriol Production at the Institute
The Łukasiewicz – Industrial Chemistry Institute has developed a technology for the production of calcitriol—one of the most technically demanding syntheses within the field of vitamin compounds. The development and implementation of this synthesis requires:
- multistage and highly precise chemical transformations,
- stringent control of reaction conditions at the microgram scale,
- advanced purification techniques, and
- measures ensuring the stability of an exceptionally sensitive active pharmaceutical ingredient (API).
Producing stable, highly pure calcitriol is a particularly complex undertaking, and only a limited number of organizations worldwide possess the capability to carry it out. The Institute’s ability to perform this synthesis represents a significant achievement, demonstrating both scientific excellence and the advanced competencies of its research and production teams.
Confirmed compliance with GMP
We are proud to announce that the Chief Pharmaceutical Inspectorate (CPI) has confirmed that the production of calcitriol at Łukasiewicz – Industrial Chemistry Institute complies with Good Manufacturing Practice (GMP) standards. This certification provides official confirmation that the Institute’s production processes meet the highest quality and safety requirements for substances intended for use in medicinal products.
