Chemical Names: Cholecalciferol
CAS: 67-97-0
Molecular Formula: C27H44O
Molecular Weight: 384.7g/mol
EINECS NO. 200-673-2
Description:
Free-flowing off-white powder consisting of fine spherical particles.
Composition:
The spherical particlescontain vitamin D3 in medium chain triglyerides 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 antioxiandant.
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. 100,000I.U/g (=2,500µg 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. 25% smaller than 150µm (100mesh USP)
Bulk density: Approx. 0.6g/ml
Stabilization/Stability:
The product is stabilized with BHT (E321). The stability of the vitamin D3 in the dry spherical particles is very good even in the presence of minerals. ;The product is stable for at least 30 months when it is stored in the original containers at room temperature (about 25oC)
Applications:
Pharmaceutical preparations:
The product is particularly suitable for use in multivitamin/mineral tablets and hard gelatin capsules. Because of the small particle size and relatively low vitamin D3 incontent of the dry spherical particles, the vitamin can be distributed very homogeneously, even in formulations with a low active content. Dry vitamin D3 tablets is also very suitable for the manufacture of vitamin D3 tablets with a high active content by direct compression.
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 100 must be handled in accordance with the Safety Data Sheet. |
