Description

Alfacalcidol is a synthetic analog of vitamin D, specifically a prohormone of calcitriol (1,25-dihydroxyvitamin D3). This compound is critical for regulating calcium and phosphate metabolism in the body, offering superior bioavailability and a faster onset of action compared to native vitamin D. It is an essential active pharmaceutical ingredient (API) primarily demanded by the global pharmaceutical industry for the formulation of prescription medications. Alfacalcidol CAS NO 41294-56-8 is a cornerstone in treatments for metabolic bone disorders, including renal osteodystrophy, hypoparathyroidism, and osteoporosis.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription drugs for calcium and bone metabolism regulation.
• Treatment of Renal Osteodystrophy: Management of bone disease in patients with chronic kidney failure.
• Hypoparathyroidism Therapy: Correction of low blood calcium levels caused by underactive parathyroid glands.
• Osteoporosis Management: Adjunct therapy to increase bone mineral density and reduce fracture risk.
• Nutritional Supplements (Rx-grade): Used in specialized, high-potency prescription vitamin D supplements.
• Veterinary Pharmaceuticals: Formulation of medications for calcium disorders in animals.
• Research & Development: Biochemical research on vitamin D receptors, calcium homeostasis, and bone biology.

Basic Information

Product Name	Alfacalcidol
CAS No.	41294-56-8
Molecular Formula	C₂₇H₄₄O₂
Molecular Weight	400.64 g/mol
Synonyms	1α-Hydroxycholecalciferol; 1α-Hydroxyvitamin D3; 1α-OH-D3; α-Calcidol; (5Z,7E)-9,10-Secocholesta-5,7,10(19)-triene-1α,3β-diol; Delakmin; One-Alpha; Alfarol
EINECS	255-296-6

Quality Control

Our Alfacalcidol is manufactured under strict quality management systems, targeting compliance with major pharmacopoeial standards such as USP, EP, and JP. Every batch undergoes comprehensive analytical testing including HPLC for assay and related substances, identification by IR and HPLC comparison, and tests for residual solvents and heavy metals. A Certificate of Analysis (COA) documenting full compliance with agreed specifications is provided with each shipment, ensuring traceability and reliability for our global pharmaceutical partners.

Storage

Preserve in a tightly closed container, protected from light. Store under an inert atmosphere (e.g., nitrogen) at a controlled room temperature of 15-25°C (59-77°F) to minimize oxidation and degradation. The container should be kept in a cool, dry, and well-ventilated area, away from heat sources and incompatible materials.

Specification

Item	Specification
Appearance	White to almost white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water (Karl Fischer)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Specific Rotation	+48° to +52° (c=1 in ethanol)

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.