Pharmaceuticals and Biochemicals/Vitamin, amino acids and coenzymes

Chemical names Retinyl acetate, all-trans retinal acetic acid ester

CAS NO. 127-47-9EINECS NO. 204-844-2

Description

Free-flowing light yellow powders consisting of fine spherical particles.

Composition

The spherical particles contain vitamin A acetate in droplets of 1-2μm embedded in a matrix of gelatin and sucrose coated with modified starch. The products contain t-butylhyd roxytoluene(BHE,E321)as an antioxidant.

Solubility

Dipersible in warm water(35-40℃), to form a milky emulsion.

Specification

Assay : Min. 500,000I.U. vitamin A(=150,000RE)per gramAbsorbance Ratios: Comply with Ph.Eur. and USPLoss on drying: max. 5%(4hours at 105℃)

Particle-size distribution

100%smaller than 425μm (40 mesh USP)min. 90%smaller than 250μm (60 mesh USP)max. 10%smaller than 150μm (100 mesh USP)

Bulk density

Approx. 0.6g/ml

Stabilization/Stability

The products are stabilized with BHT(E 321). The stability of the vitamin A in the dry spherical particles is very good even in the presence of minerals. The products have good resistance to pressure and very little vitamin A is expressed during tabletting, so that they exhibit good stability in tablets. The product is stable for at least 24 months. When it is stored in the original containers at room temperature (about 25℃)with dry place.

Packaging

5-25kg fibreboard box with AL-PE laminated liner, heat-sealed

Storage

As vitamin A is sensitive to atmospheric oxygen, light, moisture and heat, the products should be stored in the original containers at room temperature (25℃) with dry place.

Applications

Pharmaceutical preparations:The products have been developed specially for marking high-dose vitamin A tables by direct compression. Because of their tabletting properties, they are also very good for multvitamin/mineral tablets and for hard gelatin capsules.

Note:Dry vitamin A acetate 500 must be handled in accordance with the Safety Data Sheet.