Chemical Names: D-a-tocopherol acetate, D-alpha-tocopherol acetate, RRR-alpha-tocopherol acetic, 5,7,8-trimethyltocol acetate
CAS: 522250-20-4
Molecular Formula: C31H52O3
Molecular Weight: 472.8g/mol
EINECS NO. 257-757-7
Units:
1mg of D-a-tocopherol acetate=0.91 D-a-TE=1.36 former USP unit
Description:
Free flowing, almost white dry powder consisting of fine spherical particles.
Practically odourless.
Composition:
The spherical particles contain d-a-tocopheryl acetate in droplets of 1-2um embedded in a matrix of gelatin and sucrose coated with starch.
Solubility:
Dispersible in warm water (35-40°C) to form a stable milky emulsion.
Specification:
Assay: Min. 500 I.U. of vitamin E per gram (=368mg of d-a-tocopheryl acetate or 336-a-TE per gram)
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. 10% smaller than 150µm (100mesh USP)
Bulk density: Approx. 0.6g/ml
Stabilization/Stability:
The stability of the dry powder is excellent even in the presence of minerals. The e product is stable for at least 24 months when it is stored in the unopened original containers at room temperature (about 25oC) with dry place.
Applications:
Pharmaceutical preparations:
The product has been developed specially for the production of highdose “natural vitamin E tablets”, sugar coated tablets and chewable tablets by the direct compression method. The neutral taste and odour of the dry powder are a particular advantage in chewable tablets. Because of its excellent flow and tabletting properties, it is equally suitable for the manufacture of multivitamin/mineral tablets and for filling 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), with dry place.
Shelf life …24 months
Note: Natural dry Vitamin E Acetate 500 DC must be handled in accordance with the Safety Data Sheet. |
