Vitamin D3 Calcifediol Monohydrate (25-OH-D3)

Vitamin D3 Calcifediol Monohydrate (25-OH-D3) (CAS 63283-36-3) is the principal circulating metabolite of cholecalciferol, formed by hepatic 25-hydroxylation of vitamin D3. As a pre-activated intermediate on the biosynthetic pathway to the fully active form 1,25-dihydroxyvitamin D3, calcifediol monohydrate offers formulators a distinct biological starting point compared with parent cholecalciferol, making it a technically differentiated active ingredient for regulated applications in the pharmaceutical and nutraceutical sectors. Within the European regulatory framework, calcifediol monohydrate is listed in Annex II of Directive 2002/46/EC as an authorised vitamin D source for food supplements, added by Regulation (EU) 2025/352. Manufacturers developing supplement products for the EU market may therefore incorporate this ingredient with confidence in its compliance status for that specific application category.

Vitamin D, in its various forms, is associated with a range of authorised EU health claims under Regulation (EC) 432/2012. These include contributions to normal absorption and utilisation of calcium and phosphorus, maintenance of normal blood calcium levels, normal bones, normal teeth, normal muscle function, normal function of the immune system, and normal cell division. Formulators working on structure-function claims for supplement products should reference the applicable EFSA dossiers when substantiating label statements. In pharmaceutical applications, calcifediol monohydrate is used as an active substance in prescription and OTC formulations addressing vitamin D insufficiency, as well as serving as a certified reference standard for clinical 25(OH)D3 assays and analytical method development. Purity specifications typically align with Ph. Eur. or USP monograph requirements, and SoleChem can advise on available grades to match your quality system requirements.

For nutraceutical and dietary supplement manufacturers, calcifediol monohydrate is supplied in crystalline and powder forms suitable for encapsulation, tablet compression, and sachet formats. Its molecular weight of approximately 400.6 Da and defined monohydrate stoichiometry support reproducible dosing calculations across finished product development. Standard potency reference: 1 IU vitamin D activity corresponds to 0.025 mcg of cholecalciferol equivalent. SoleChem supplies Vitamin D3 Calcifediol Monohydrate in packaging configurations appropriate for both development-scale and commercial-scale procurement. Small lots are available in 1–5 kg units for formulation trials and pilot batches; bulk orders are fulfilled in 25 kg drums or cartons with full documentation including CoA, safety data sheet, and regulatory support files upon request.

Handling and storage require strict attention: the product carries a Danger signal word under GHS classification, and standard precautions for potent steroidal compounds apply, including controlled-temperature storage, inert-atmosphere handling, and appropriate personal protective equipment. Full safety documentation is provided with each shipment in accordance with EU REACH requirements.