all-rac-α-Tocopheryl acetate (Vitamin E acetate), EMPROVE® ESSENTIAL USP, Ph. Eur., BP, FCC suitable for use as excipient, SAFC®
Supplier: MERCK PRODUCTION CHEMICALS
Certificates
About this item
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
CAS Number:7695-91-2
:52225-20-4
Formula:C₃₁H₅₂O₃
MDL Number:MFCD00072042
Molecular Weight:472.75 g/mol
EINECS:231-710-0
Specifications
- Environmentally Preferable:
Specifications
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
Specification Test Results
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