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Compositional guideline: Tocotrienols complex - palm

8 July 2013

Name of the ingredient

Tocotrienols complex - palm (AAN)

Definition of the ingredient

Tocotrienols complex - palm is a mixture of α-tocopherol and tocotrienols derived from the oil of the palm fruit, Elaeis guineensis. The manufacturing process involves either alcoholic trans-esterification followed by distillation or multiple distillation steps. The phyto-tocotrienols complex should contain ‘α-tocopherol’ and ‘total tocotrienols’1 in a ratio of approximately 1:3.

Table 1: Ingredient specific requirements

Test Method reference Acceptance criteria
Description
Appearance Visual Amber to reddish coloured oil suspension
Characteristics
Moisture USP<921> Not more than 1%
Identification
Tocotrienols complex - palm HPLC Complies with the chromatogram for the authenticated reference materials
Assay
Phyto-tocotrienols complex2 HPLC 20-60%
Alpha-tocopherol HPLC

3.5-18.0%

Alpha-tocotrienol HPLC

4.5-17.0%

Beta-tocotrienol HPLC

0.3-2.0%

Gamma-tocotrienol HPLC

6.0-24.0%

Delta-tocotrienol HPLC

1.0-9.0%

Monoglycerides/diglycerides/ triglycerides GC 10.0-70.0%
Phytosterol complex GC 1.0-12.0%
Palm squalene GC 1.0-15.0%
Notes
  1. The sum of alpha-tocotrienol, beta-tocotrienol, gamma-tocotrienol and delta-tocotrienol
  2. The sum of alpha-tocopherol, alpha-tocotrienol, beta-tocotrienol, gamma-tocotrienol and delta-tocotrienol

Table 2: Incidental constituents

Test Method reference Acceptance criteria
Residual solvents
Residual solvents Ph Eur method 2.4.24 Complies
Incidental metals and non-metals
Heavy metals (as lead) BP (Appendix VII) Not more than 20 ppm
Pesticide residues and environmental contaminants (including agricultural and veterinary substances)
Pesticide residues Ph Eur method 2.8.13 Complies
Other organic or inorganic impurities or toxins
Peroxide value BP (Appendix X F) Not more than 5
Microbiology
While substance manufacturers are encouraged to include limits for objectionable microorganisms, it is the product into which those substances are formulated that is subject to a legally binding set of criteria. The Therapeutic Goods Order No. 77 'Microbiological Standards for Medicines' mandates that any finished product that contains the ingredient, alone or in combination with other ingredients, must comply with the microbial acceptance criteria set by Clause 9 of the Order.

Key to abbreviations

BP = British Pharmacopoeia

GC = Gas chromatography

HPLC = High-pressure liquid chromatography

Ph Eur = European Pharmacopoeia

USP = United States Pharmacopoeia

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