Description
Product name D-alpha Tocopheryl Acid Succinate
***5IU
Character A white or almost
white, crystalline granule,
Practically insoluble in water,
soluble in acetone and in ethanol, very soluble in methylene
chloride.
Identification
A. It complies with the test for absorbance
B. Examine by infrared absorption spectrophotometry (2.2.*4),
comparing with the
spectrum obtained with RRR--tocopheryl hydrogen
succinate CRS.
C. Examine by thin-layer chromatography (2.2.*7),
D. After saponification, the resulting RRR--tocopherol is **6.7°
dextrorotatory (2.2.7). The specific optical
rotation after oxidation to the quinone form is at least +
*4.
Absorbance Maximum absorbance
(**4nm)
Minimum absorbance(**4nm)
Acid value Between **1 and **8,
determined on1.*0 g.
Free tocopherol. Not more than 1.0 per
cent
Heavy metals
As ≤ 3ppm
Hg ≤ 1ppm
Cd ≤1ppm
Lead
≤ 2ppm
Sulphated ash Not more than 0.1 per
cent
Bulk Density 0.*0ml/g- 0.*2ml/g
Particle Size *9% thru a *0 mesh and
NMT *0% thru a **0
mesh
ASSAY
*****2%
Residual solvents
hexane≤**0ppm
butanone≤0.5%
Microbials Total plate
count NMT
**0cfu/g
Yeast and
mold
NMT
*0cfu/g
E.
coli.
Negative
Salmonella
Negative
S.Aureus
Negative
