all-rac-α-Tocopheryl acetate (Vitamin E acetate), EMPROVE® ESSENTIAL Ph. Eur., BP, USP, FCC, SAFC®
Supplier: MERCK PRODUCTION CHEMICALS
Synonyms:
(±)-α-Tocopherol acetate, all-rac-α-Tocopheryl acetate, Vitamine E acetate, DL-alpha-Tocopheryl acetate, 2,5,7,8-Tetramethyl-2-(4,8,12-trimethyltridecyl)chroman-6-yl acetate
5.00952.0100
5.00952.5000
5.00952.0100EA
350
EUR
5.00952.0100
5.00952.5000
all-rac-α-Tocopheryl acetate (Vitamin E acetate), EMPROVE® ESSENTIAL Ph. Eur., BP, USP, FCC, SAFC®
DL-α-Tocopherol acetate
Residues of metal catalysts or metal reagents acc. to EMEA/CHMP/SWP/4446/2000 are not likely to be present.
Corresponds to Ph. Eur., BP, USP, FCC
Formula:
C₃₁H₅₂O₃ MW: 472,75 g/mol |
MDL Number:
MFCD00072042 CAS Number: 7695-91-2 EINECS: 231-710-0 |
Specification Test Results
Assay (GC, Ph. Eur.) | 96.5 - 102.0 % |
Assay (GC, USP) | 96.0 - 102.0 % |
Assay (GC, FCC) | 960 - 1020 I.U./g |
Identity (IR) | conforms |
Optical rotation α 20/D (100 g/l; anhydrous ethanol) | -0.01 - 0.01 ° |
As (Arsenic) | ≤ 0.0003 % |
Cu (Copper) | ≤ 0.0025 % |
Pb (Lead) | ≤ 0.0002 % |
Zn (Zinc) | ≤ 0.0010 % |
Acetic acid (HS-GC) | ≤ 5000 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., impurity C) | ≤ 0.5 % |
Related substances (Ph. Eur., sum of impurities D and E) | ≤ 1.0 % |
Related substances (Ph. Eur., any other impurity) | ≤ 0.25 % |
Related substances (Ph. Eur., total impurities) | ≤ 2.5 % |
Acidity | conforms |
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