Vitamin D3 (Cholecalciferol)
Cholecalciferol · C27H44O
Bulk cholecalciferol in USP/Ph. Eur./BP crystalline 40 MIU/g, 1.0 and 4.0 MIU/g oil dilutions and 100,000 IU/g cold-water-dispersible beadlets. Lanolin-derived and vegan lichen options.
Specifications
| Chemical name | Cholecalciferol (Vitamin D3, colecalciferol) |
| CAS number | 67-97-0 |
| Molecular formula | C27H44O (molecular weight 384.64) |
| Assay / potency | Crystalline: 97.0-103.0% C27H44O (USP, Ph. Eur., BP), equal to 40,000,000 IU/g (1 IU = 0.025 µg). Concentrates: 90.0-110.0% of the labelled IU/g |
| Concentrate grades | Oily form not less than 500,000 IU/g (supplied at 1.0 and 4.0 MIU/g); powder and water-dispersible forms not less than 100,000 IU/g |
| Appearance | Crystalline grade: white or almost white crystals. Beadlet grade: off-white to yellowish free-flowing particles in a starch, acacia and sucrose matrix. Oil grade: clear yellow liquid |
| Solubility | Practically insoluble in water; freely soluble in ethanol (96%); soluble in trimethylpentane and in fatty oils. Water-dispersible beadlets disperse in cold water |
| Specific optical rotation | +105° to +112° (Ph. Eur., in ethanol) |
| Melting range | Approximately 84-85 °C (crystalline) |
| Loss on drying | Reported on the certificate of analysis for beadlet and powder grades; the pharmacopoeial monograph for crystalline cholecalciferol sets no loss-on-drying limit |
| Heavy metals | Elemental impurities controlled to ICH Q3D / USP <232>; heavy metals as Pb not more than 10 ppm on the classical limit test |
| HS code | 2936 29 40 (ITC-HS India) - Other vitamins and their derivatives: Vitamin D |
Cholecalciferol is the D3 form of vitamin D, CAS 67-97-0, molecular formula C27H44O, molecular weight 384.64. Commercial material is made by ultraviolet irradiation of 7-dehydrocholesterol obtained from lanolin (wool grease), followed by thermal isomerisation of the previtamin to cholecalciferol; a vegan route from selected lichen species is available where an animal-free declaration is required. Pharmacopoeial crystalline material assays 97.0 to 103.0 per cent C27H44O under USP, Ph. Eur. and BP. Potency is expressed against the international unit, where 1 IU equals 0.025 µg, so pure cholecalciferol carries 40,000,000 IU per gram. In nutrition, vitamin D contributes to normal absorption and utilisation of calcium and phosphorus and to the maintenance of normal bone; it is a permitted fortificant in most export markets and is dosed at microgram level, which is why nearly all industrial use is of diluted, stabilised forms rather than the crystal.
We supply four working formats. Crystalline cholecalciferol at 40 MIU/g suits customers who prepare their own dilutions under controlled conditions. Oily concentrates in refined vegetable oil or MCT at 1.0 and 4.0 MIU/g follow the Ph. Eur. cholecalciferol concentrate (oily form) pattern of not less than 500,000 IU/g with content 90.0 to 110.0 per cent of the labelled value, and are the usual choice for softgels, oral drops and edible-oil fortification. Powder and cold-water-dispersible beadlets at 100,000 IU/g match the Ph. Eur. concentrate (powder form) and (water-dispersible form) monographs; the beadlet is cholecalciferol held in medium-chain triglycerides within a starch-coated matrix of acacia and sucrose, with dl-alpha-tocopherol as antioxidant, giving free-flowing particles that survive tabletting, dry blending and aqueous dosing in dairy and plant-based drinks. Cholecalciferol is sensitive to oxygen, light, heat and acid, so all grades are filled under nitrogen and shipped protected from light.
Every consignment is released against a batch certificate of analysis covering assay or potency by HPLC, identity by UV and infrared absorption, specific optical rotation, appearance, residual solvents, elemental impurities to ICH Q3D, and microbiological limits on the diluted grades. Documentation packs include MSDS, certificate of origin, allergen, GMO and BSE/TSE statements, nutritional and specification sheets, and where required halal, kosher and vegan certificates. Material is manufactured in GMP and FSSC 22000 certified plants, supported by stability data, and exported worldwide with cold-chain handling for crystalline material.
Applications
Softgels and oral dropsTablet and capsule blendsCold-water-dispersible premixesDairy and plant-milk fortificationEdible oil and margarine fortificationGummies and chewablesInfant and clinical nutritionVegan supplement linesAnimal feed premixes
Available grades
USP, Ph. Eur., BP, FCC, food grade, feed grade; crystalline 40 MIU/g, oily concentrate 1.0 and 4.0 MIU/g, powder and cold-water-dispersible beadlet 100,000 IU/g; lanolin-sourced and vegan lichen-sourced
Packaging: Crystalline cholecalciferol is filled under nitrogen into 25 g, 100 g and 1 kg amber glass or aluminium bottles and shipped chilled at 2-8 °C inside insulated fibre drums; cold-water-dispersible beadlets are packed in 25 kg fibre drums with a double food-grade LDPE liner inside an aluminium-foil bag; oil dilutions go in 5 kg and 25 kg lacquered tins or HDPE jerricans under nitrogen. All outers are palletised and shrink-wrapped for sea or air export.