DL-α-Tocoferol, powder_dried, EMPROVE® ESSENTIAL USP, Ph. Eur., BP suitable for use as excipient, SAFC®
Proveedor: MERCK PRODUCTION CHEMICALS
Sinónimos:
(±)-α-Tocoferol, all-rac-α-Tocoferol, 3,4-Dihidro-2,5,7,8-tetrametil-2-(4,8,12-trimetiltridecil)-2H-benzopirano-6-ol
5.00859.2500
5.00859.9029
5.00859.2500EA
932
EUR
5.00859.2500
5.00859.9029
DL-α-Tocoferol, powder_dried, EMPROVE® ESSENTIAL USP, Ph. Eur., BP suitable for use as excipient, SAFC®
DL-α-Tocoferol
Vitamin E (50 g all-rac-α-tocopheryl acetate in 100 g substance)
|
Formula:
C₂₉H₅₀O₂ MW: 430.71 g/mol |
Número MDL:
MFCD00072051 Núm. CAS: 10191-41-0 EINECS: 233-466-0 |
Resultados test especificaciones
| 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 |
| corresponds to Ph Eur, BP, USP |
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