Description

Calcifediol Monohydrate is a key intermediate metabolite of vitamin D3, also known as 25-hydroxyvitamin D3. This compound is of critical importance for its role in calcium and phosphate homeostasis, serving as the primary circulating form of vitamin D and the most reliable indicator of an individual's vitamin D status. It is essential for manufacturers in the pharmaceutical, nutraceutical, and research sectors who require a high-purity standard for diagnostic assays, active pharmaceutical ingredient (API) synthesis, and nutritional supplement formulation.

Application

• Pharmaceutical API Intermediate: A crucial precursor in the synthesis of active vitamin D hormone (calcitriol) and other vitamin D analogs for treating osteoporosis, renal osteodystrophy, and hypoparathyroidism.
• Clinical Diagnostic Reagents: Used as a certified reference standard in immunoassays and liquid chromatography-mass spectrometry (LC-MS) kits to accurately measure 25-hydroxyvitamin D levels in human serum.
• Nutraceutical Formulations: Incorporated into advanced dietary supplements aimed at correcting and maintaining optimal vitamin D levels, especially in cases of malabsorption.
• Biochemical Research: Serves as a vital tool for studying vitamin D metabolism, receptor binding, and its role in cell differentiation, immune function, and gene expression.
• Veterinary Medicine: Used in supplements and treatments for calcium and bone disorders in livestock, poultry, and companion animals.

Basic Information

Product Name	Calcifediol Monohydrate
CAS No.	63283-36-3
Molecular Formula	C27H44O3 • H2O
Molecular Weight	418.65 g/mol (Monohydrate)
Synonyms	25-Hydroxyvitamin D3 Monohydrate; 25-Hydroxycholecalciferol Monohydrate; 25-OH-D3; 25(OH)D3; Hy-D; Calderol (brand name); (3β,5Z,7E)-9,10-Secocholesta-5,7,10(19)-triene-3,25-diol Monohydrate
EINECS	Contact for details

Quality Control

Our Calcifediol Monohydrate is produced under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation by IR and NMR spectroscopy, to ensure it meets stringent specifications for pharmaceutical and research use. Certificates of Analysis (COA) detailing all test results are provided to guarantee traceability, consistency, and compliance with relevant guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 2-8°C. This product is hygroscopic (moisture-sensitive) and must be kept under inert atmosphere or desiccated conditions after opening to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Water Content (KF)	3.5% - 5.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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