DL-α-Tocopherol (Vitamin E), dried powder, EMPROVE® ESSENTIAL USP, Ph. Eur., BP 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
- Environmentally Preferable:
- all-rac-α-Tocopheryl acetate content (GC, Ph. Eur.):50.0 - 57.5 %
- all-rac-α-Tocopheryl acetate content (GC, USP):49.0 - 57.5 %
- Identity (TLC):conforms
- Identity (GC):conforms
- Optical rotation α 20/D (all-rac-α-Tocopheryl acetate):-0.01 - 0.01 °
- 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 (Ph.Eur./USP/ICH):excluded by production process
- Loss on drying (130 °C, vacuum, 4 h):≤ 5.0 %
- Total aerobic microbial count (TAMC):≤ 100 CFU/g
- Total combined yeasts/moulds count (TYMC):≤ 100 CFU/g
- Bile-tolerant gram-negative bacteria (absent in 1 g):passes test
- Candida albicans (absent in 1 g):passes test
- Escherichia coli (absent in 1 g):passes test
- Pseudomonas aeruginosa (absent in 1 g):passes test
- Salmonella (absent in 10 g):passes test
- Staphylococcus aureus (absent in 1 g):passes test
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