Description

Alfacalcidol is a synthetic analog of vitamin D, specifically a prodrug of calcitriol, designed for enhanced metabolic stability and targeted biological activity. This compound is critically important for regulating calcium and phosphate metabolism within the body, making it a key active pharmaceutical ingredient (API). It is primarily required by the pharmaceutical industry for the formulation of treatments for conditions such as hypocalcemia, renal osteodystrophy, and secondary hyperparathyroidism associated with chronic kidney disease.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription medications for calcium and bone metabolism disorders.
• Treatment of Hypocalcemia: Used in formulations to correct low serum calcium levels, particularly in patients with hypoparathyroidism.
• Renal Osteodystrophy Management: A cornerstone therapy for preventing and treating bone disease in patients with chronic kidney failure.
• Secondary Hyperparathyroidism: Essential for controlling parathyroid hormone levels in renal-impaired patients.
• Osteoporosis Adjunct Therapy: Investigated and utilized in some therapeutic regimens for bone density support.
• Nutritional and Metabolic Research: Serves as a critical reference standard and reagent in biochemical and pharmacological research studies.

Basic Information

Product Name	Alfacalcidol
CAS No.	147125-21-1
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; 1α,25-Dihydroxycholecalciferol precursor
EINECS	Contact for details

Quality Control

Our Alfacalcidol is manufactured under strict quality systems to ensure it meets the high-purity standards required for pharmaceutical applications. Each batch undergoes comprehensive analytical testing, including identification, assay, and impurity profiling via HPLC and other pharmacopeial methods. Certificates of Analysis (COA) confirming compliance with relevant specifications, including in-process references to ICH guidelines, are available upon request.

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 incompatible materials.

Specification

Item	Specification
Appearance	White to almost white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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