Calcifediol Monohydrate, also known as calcidiol or 25-hydroxyvitamin D3, is a crucial metabolite of vitamin D that plays a vital role in calcium homeostasis and bone health. With CAS number 63283-36-3 and molecular formula C27H44O2·H2O, this compound serves as the primary circulating form of vitamin D in the body and is essential for maintaining optimal health.

What is Calcifediol Monohydrate?

Calcifediol (25-hydroxyvitamin D3 or 25(OH)D3) is the major circulating metabolite of vitamin D3 (cholecalciferol). It is produced in the liver through hydroxylation of vitamin D3 by the enzyme vitamin D 25-hydroxylase. Calcifediol serves as a crucial intermediate between vitamin D and its active form, calcitriol (1,25-dihydroxyvitamin D3).

The monohydrate form ensures stability and proper storage of this sensitive vitamin D metabolite. As the best indicator of the body's vitamin D stores, calcifediol is clinically measured to assess vitamin D status in patients.

What Are the Benefits?

Treatment of Vitamin D Deficiency

Calcifediol is highly effective in treating vitamin D deficiency states. Unlike vitamin D supplements that require hepatic conversion, calcifediol provides the ready-to-use form that the body can immediately utilize.

Management of Secondary Hyperparathyroidism

One of the most significant therapeutic applications of calcifediol is in managing secondary hyperparathyroidism (SHPT) associated with chronic kidney disease (CKD). Research has demonstrated that extended-release calcifediol effectively controls SHPT in patients with stage 3-4 CKD and vitamin D insufficiency.

Improvement of Calcium Absorption

Calcifediol enhances intestinal calcium absorption, supporting proper bone mineralization and preventing conditions like osteomalacia and rickets. It helps maintain adequate serum calcium levels essential for neuromuscular function and bone health.

Anti-inflammatory Properties

Studies have shown that calcifediol exhibits anti-inflammatory effects by downregulating TLR4 and JAK1/STAT3 signaling pathways. These properties contribute to its therapeutic potential in various inflammatory conditions.

What Are the Uses?

Pharmaceutical Applications

In the pharmaceutical industry, calcifediol is used as:

• Treatment for chronic kidney disease: Extended-release calcifediol (ERC) capsules (marketed as Rayaldee®) are FDA-approved for treating secondary hyperparathyroidism in adults with stage 3-4 CKD
• Therapy for vitamin D insufficiency: Used when patients have low serum 25-hydroxyvitamin D levels
• Rickets and osteomalacia treatment: Effective in treating both azotemic and non-azotemic patients with these conditions
• Dialysis patient support: Helps combat hypocalcemia in dialysis patients

Research and Biochemical Applications

Calcifediol is widely used in research settings as:

• A biochemical marker for vitamin D status assessment
• A precursor for calcitriol synthesis in research laboratories
• A reference standard in vitamin D metabolism studies

Safety and Side Effects

General Safety Profile

Calcifediol is generally well-tolerated when used as directed. However, it should be used under medical supervision, particularly in patients with kidney disease or calcium metabolism disorders.

Common Side Effects

Potential side effects may include:

• Székrekedés
• Shortness of breath
• Coughing
• Low levels of red blood cells (anemia)

Important Precautions

• Healthcare providers should monitor blood levels of calcium, parathyroid hormone (PTH), and vitamin D before and during treatment
• Use with caution in patients with hypercalcemia or vitamin D toxicity
• Consult a healthcare professional before starting supplementation
• Not recommended during pregnancy or breastfeeding without medical advice

Chemical Specifications

CAS-szám	63283-36-3
Molekuláris képlet	C27H44O2·H2O
Molekulatömeg	418.65 g/mol
Megjelenés	Fehér vagy törtfehér kristályos por
Oldhatóság	Soluble in organic solvents; practically insoluble in water
Tisztaság	Typically ≥98%
Tárolás	Store at -20°C, protected from light and moisture

Frequently Asked Questions

What is the difference between calcifediol and calcitriol?

Calcifediol (25-hydroxyvitamin D3) is the storage form produced in the liver, while calcitriol (1,25-dihydroxyvitamin D3) is the active form produced in the kidneys. Calcifediol has a longer half-life and is used as the primary marker for vitamin D status.

How is calcifediol different from vitamin D3 supplements?

Vitamin D3 (cholecalciferol) requires conversion in the liver to become calcifediol. Calcifediol provides the direct form that the body can use immediately, making it more effective for patients with liver problems or those who need rapid vitamin D repletion.

Who should take calcifediol?

Calcifediol is typically prescribed for patients with chronic kidney disease (stages 3-4) with secondary hyperparathyroidism, those with vitamin D insufficiency, and patients with conditions affecting vitamin D metabolism.

Is calcifediol safe for long-term use?

When monitored by healthcare professionals, calcifediol can be used long-term. Regular blood tests are required to ensure proper dosing and to avoid hypercalcemia.

Why Choose Our Calcifediol Monohydrate?

• High purity: Our calcifediol monohydrate meets or exceeds pharmaceutical standards with ≥98% purity
• Quality tested: Each batch undergoes rigorous quality control testing including HPLC, IR, and NMR analysis
• Competitive pricing: Factory-direct pricing for bulk orders
• Reliable supply: Stable production capacity to meet your pharmaceutical and research needs
• Technical support: Our team provides comprehensive technical documentation and assistance

Contact us today to request a quote or learn more about our vitamin D derivatives and pharmaceutical intermediates!

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