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LC5495 all-rac-α-Tocopherol suitable for use as excipient exp Ph Eur,BP,USP,E 307

 

Order number	Packaging	Quantity	Price €
AC32495	Alu bottle	5 kg	Inquire
AC32495	Alu bottle	25 kg	Inquire

 

Product information
Grade	Ph Eur,BP,USP,E 307
Synonyms	Vitamin E alcohol
Hill Formula	C29H50O2
HS Code	2936 28 00
EC number	233-466-0
Molar mass	430.71 g/mol
CAS number	10191-41-0

 

Chemical and physical data
Ignition temperature	280 °C
Solubility	< – 0.001 g/l (20 °C)
Melting point	2.5 – 3.5 °C
Molar mass	430.71 g/mol
Density	0.95 g/cm3 (20 °C)
Boiling point	393 °C (1013 hPa)
Vapor pressure	13 hPa (155 °C)
Flash point	254 °C

 

Safety information
RTECS	GA8746000
Storage	10 Combustible liquids not in Storage Class 3
WGK	WGK 1 slightly water endangering
Disposal	3 Relatively unreactive organic reagents should be collected in container A. If halogenated, they should be collected in container B. For solid residues use container C.

 

Toxicological data
LD 50 oral	LD50 rat > 4000 mg/kg

 

 

Safety information
Assay – GC, Ph. Eur.	96.0 – 102.0 %
– GC, USP	96.0 – 102.0 %
Identity – IR	conforms
– GC	conforms
Optical rotation α 20/D (100 g/l; anhydrous ethanol)	-0.01 – 0.01 °
Refractive index (n 20/D)	1.503 – 1.507
Spec. Absorptivity A 1%/1cm (292 nm; 0,1 g/l, anhydrous ethanol)	72 – 76
Heavy metals (as Pb)	≤ 0.001 %
As (Arsenic)	≤ 0.0003 %
Cu (Copper)	≤ 0.0010 %
Hg (Mercury)	≤ 0.0001 %
Pb (Lead)	≤ 0.0002 %
Zn (Zinc)	≤ 0.0025 %
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
Related substances – Ph. Eur., impurity A	≤ 0.5 %
– Ph. Eur., impurity B	≤ 1.5 %
– Ph. Eur., sum of impurities C and D	≤ 1.0 %
– Ph. Eur, any other impurity	≤ 0.25 %
– Ph.Eur., total impurities	≤ 2.5 %
Organic volatile impurities (USP/NF)	conforms
Acidity	conforms
Sulfated ash (600 °C)	≤ 0.1 %