Vitapherole® E-1000 Acetate Non-GMO

(d-alpha tocopheryl acetate)

Common Names

  • Chemical Name: d-alpha tocopheryl acetate. 2R, 4´R, 8´R-alpha-tocopheryl acetate
  • Vitamin E Acetate
  • INCI Name: tocopheryl acetate
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Additional Information

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Download: Vitapherole E-1000 Acetate Non-GMO PDS (PDF, 523 KB)

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Identification

Common NameEmpirical FormulaMolecular WeightCAS
d-alpha tocopheryl acetateC31H52O347358-95-7

Standards

  • This product complies with current EP and USP-NF standards, FCC and Regulation (EC) Nº 852/2004.
  • Kosher (“Circle U”) and Halal certified. Produced under UNE EN ISO 9001: 2008 standard.
  • Non GMO (IP). It is not subjected to be labelled under Regulations (EU) 1829/2003 and 1830/2003.
  • This product does not contain allergens according to Regulation (EU) Nº1169/2011 so; it is not required labelling declaration as being potential allergen.
  • D-alpha tocopheryl acetate is generally recognized as safe (GRAS) by FDA (21 CFR Part 182 Sec. 182.8892).

Ingredients/Composition

GC method according to IT-02-L

D-alpha Tocopheryl Acetate:735 mg/g min.(73.5 %) min.
Vegetable Oil (sunflower):265 mg/g max.(26.5 %) max.

Quality Control Assay

(Parameters analyzed per batch)

Appearance: Clear, pale yellow viscous oil
Taste: Mild, characteristic
Odour: Little to none
Colour: Max. 8 Gardner Units
Viscosity (60ºC): 90– 100 cP
Specific gravity/Density (25ºC): 0.93 – 0.96g/cm3

Potency: 1000 I.U/g (min)
Acidity: <0.35 ml KOH 0.1N /g (According to EP, USP and ISO 660:2009)
Benzo (a) pyrene: < 2 ppb (As per EC Regulation (EU) 835/2011)
Sum of Benzo(a) pyrene, Benzo(a) anthracene, Benzo(b) fluoranthene and Chrysene: < 10 ppb
(As per EC Regulation (EU) 835/2011)

(Parameters analyzed periodically based on statistical data)

Specific Rotation: (  ) D25. Min. + 24º (for 100% concentration) (As per USP)

Heavy Metals: Pb: <0.1ppm Hg:<0.1ppm Cd: <1ppm As: <1ppm
(As per Commission Regulation (EC) Nº 629/2008, amending Regulation (EC) Nº 1881/2006)

Microbiological Tests: E. Coli: None cfu/g (In compliance with EP and RD 3177/83)

  • Salmonella: None cfu/25g
  • Listeria Monocytogenes: None cfu/10 g
  • Shigella: None cfu/10 g
  • Clostridium Perfringens: None cfu/g
  • Staphylococcus Aureus: None cfu/g
  • Enterobacteriaceae: max 100 cfu/g
  • Total Aerobic Count: max 1000 cfu/g
  • Yeast & Moulds: max 100 cfu/g

Residual Solvents: In compliance with limits established in EP and USP for Class I solvents. This product meets as well Directive 2009/32/EC.

Dioxins:
- Sum of dioxins (WHO-PCDD/F-TEQ) 0,75 pg/g fat
- Sum of dioxins and dioxin-like PCBS (WHO-PCDD/F-PCB-TEQ) 1, 25 pg/g fat
- Sum of PCB28, PCB52, PCB101, PCB138, PCB153 and PCB180 (ICES – 6) 40 ng/g fat
(In compliance with Commission Regulation (EU) Nº 1259/2011)

Pesticides: In compliance with Regulation (EC) Nº 396/2005, amending Council Directive 91/414/EEC, and according to current European Pharmacopoeia (EP).

Properties and Conditions

Solubility: Insoluble in water. Soluble in ethanol, animal fats and vegetable oils, essential and mineraloils. Miscible with organic solvents.

Stability: Unstable to light, heat, alkali and oxidizing conditions.

Storage: Ambient temperature. Nitrogen blanketing and protection from light, moisture and air. Store in tightly closed containers.

Shelf Life: 48 months from packaging date (unopened).

Packaging: 20 and 190 kg containers are supplied for this product.
(In compliance with Commission Regulation (EU) Nº 10/2011 and FDA 21 CFR)

Labelling: All products produced using “Vitapherole® E-1000 acetate Non GMO” may be labelled as“natural source Vitamin E”.
The product is in compliance with Directive 2000/13/EC regarding labelling of foodstuffs and with Regulation (EC) Nº 1223/2009 on cosmetic products (Art.19 Labelling).

Uses: “Vitapherole® E-1000 acetate Non GMO” is a natural antioxidant widely used in food and cosmetic industries to avoid the negative effects of oxidation.

This product may be added (as a Vitamin) to foods and can be used in the manufacturing of food supplements (mainly soft gelatine capsules) according to Commission Regulation (EC) Nº 1170/2009 and cosmetics as per Regulation (EC) Nº 1223/2009.

This product has not been irradiated at any point during the manufacturing process

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