all-rac-α-Tocopherol 96.0-102.0%, EMPROVE® ESSENTIAL USP, Ph. Eur., BP, E307 suitable for use as excipient, SAFC®

: (±)-α-Tocopherol, Vitamin E Alcohol, all-rac-α-Tocopherol, 3,4-Dihydro-2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-2H-benzopyran-6-ol, 2,5,7,8-Tetramethyl-2-(4,8,12-trimethyltridecyl)chroman-6-ol, DL-alpha-Tocopherol, Vitamin E

:10191-41-0

:1406-66-2

:C₂₉H₅₀O₂

:MFCD00072051

:430.71 g/mol

:233-466-0

:GHS07

:Ambient

Environmentally Preferable:

Assay (GC, Ph. Eur.):
96.0 - 102.0 %
Assay (GC, USP):
96.0 - 102.0 %
Identity (IR):
conforms
Identity (GC):
conforms
Identity (colour reaction):
conforms
Appearance:
clear, colourless to yellow-brownish, viscous, oily liquid; almost odourless
Acidity:
conforms
Optical rotation α 20/D (100 g/l; anhydrous ethanol):
-0.01 - 0.01 °
Optical rotation α 25/D (100 g/l; chloroforme):
-0.05 - 0.05 °
Refractive index (n 20/D):
1.503 - 1.507
Spec. Absorptivity A 1%/1cm (292 nm; 0,1 g/l, anhydrous ethanol):
72 - 76
Spec. Absorptivity A1%/1cm (292 nm; 0,05 g/l , anhydrous Ethanol):
71 - 76
Heavy metals (as Pb):
≤ 10 ppm
As (Arsenic):
≤ 3 ppm
Cu (Copper):
≤ 10 ppm
Hg (Mercury):
≤ 1 ppm
Pb (Lead):
≤ 2 ppm
Zn (Zinc)#:
≤ 25 ppm
Heptane (HS-GC):
≤ 5000 ppm
Methanol (HS-GC):
≤ 3000 ppm
Pyridine (HS-GC):
≤ 200 ppm
Toluene (HS-GC):
≤ 890 ppm
Other residual solvents (ICH Q3C):
excluded by manucfacturing process
Related substances (Ph. Eur., impurity A):
≤ 0.5 %
Related substances (Ph. Eur., impurity B):
≤ 1.5 %
Related substances (Ph. Eur., sum of impurities C and D):
≤ 1.0 %
Related substances (Ph. Eur., any other impurity):
≤ 0.25 %
Related substances (Ph. Eur., total impurities):
≤ 2.5 %
Sulfated ash (600 °C):
≤ 0.1 %