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5.00952 SAFC

all-rac-α-Tocopheryl acetate

(Vitamin E acetate) EMPROVE® ESSENTIAL Ph Eur,BP,USP,FCC

  • CAS Number 7695-91-2

  • Empirical Formula (Hill Notation) C31H52O3

  • Molecular Weight 472.74

  •  EC Index Number 231-710-0

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Properties

packaging   100 g in Alu bottle (5009520100)
  5 kg in Alu bottle (5009525000)
potency   >5000 mg/kg LD50, oral (Rat)
reg. compliance   FCC
storage conditions   Store at +15°C to +25°C.
transition temp   flash point 210 °C
grade   BP
  Ph Eur
  USP
density   0.96 g/cm3 at 20 °C
autoignition temp.   303 °C
mp   -27.5 °C

Description

Analysis Note

Assay (GC, Ph Eur)96.5 - 102.0 %Assay (GC, USP)96.0 - 102.0 %Assay (GC, FCC)960 - 1020 I.U./gIdentity (IR)conformsOptical 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 ppmHeptane (HS-GC)≤ 5000 ppmMethanol (HS-GC)≤ 3000 ppmPyridine (HS-GC)≤ 200 ppmToluene (HS-GC)≤ 890 ppmOther residual solvents (ICH Q3C)excluded by manucfacturing processRelated 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 %AcidityconformsElemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).Corresponds to Ph. Eur., BP, USP, FCC

General description

(Vitamin E acetate) EMPROVE® ESSENTIAL Ph Eur,BP,USP,FCC

Safety & Documentation

Safety Information

WGK Germany 
1
RTECS 
GA8747000

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