Chemical Names: Cholecalciferol
CAS: 67-97-0
Molecular Formula: C27H44O
Molecular Weight: 384.7g/mol
EINECS NO. 200-673-2
Description:
Free-flowing cream-coloured powder consisting of fine spherical particles.
Composition:
The powder particles contain vitamin D3 in medium chain triglycerides in droplets of 1-2um embedded in a matrix of gelatin and sucrose and coated with modified starch. The product contains t-butylhydroxytoluene (BHT, E321) and DL-a-tocopherol (E307) as an antioxidant.
Solubility:
The product can be dispersed in warm water (35-40°C) to form a milky emulsion.
Practically no vitamin D can be extracted from the spherical particles with ether.
Specification:
Assay: Min. 850,000I.U/g (=21,250µg cholecalciferol/g)
Loss on drying: =5% (4 hours at 105°C)
Monographs:
The vitamin complies with the current Ph., Eur and USP monographs.
Particle-size distribution:
100 % smaller than 425µm (40mesh USP)
min. 90% smaller than 250µm (60mesh USP)
max. 45% smaller than 150µm (100mesh USP)
Bulk density: Approx. 0.6g/ml
Stabilization/Stability:
This product is stabilized with BHT (E321). The stability of the vitamin D3 in the dry powder is very good even in the present minerals. The product has good resistance to pressure and very little vitamin D3 is expressed during tabletting so that it exhibits good stability in tablets. The product is stable for at least 30 months when it is room temperature (about 25oC)
Applications:
Pharmaceutical preparations:
Because of its excellent tabletting and flow properties, the product is suitable both for direct compression (tablets with vitamin D3 as the sole active ingredient, multivitamin tablets. Multivitamin/mineral tablets etc.) and for the manufacture of hard gelatin capsules.
Packaging … 5-25kg fibreboard box with AL-PE laminated liner, heat-sealed
Storage … The product should be stored in the original containers at room temperature (about 25°C)
Shelf life …30 months
Note: Dry Vitamin D3 850 must be handled in accordance with the Safety Data Sheet. |
