Tocotrienols complex - palm: Proposed revision of draft compositional guideline

Proposed revision of draft compositional guideline for tocotrienols complex - palm

Name of the ingredient

Tocotrienols complex - palm (AAN)

Definition of the ingredient

Tocotrienols complex - palm is a mixture of tocotrienols and α-tocopherol derived from the oil of the palm fruit, Elaeis guinensis. The manufacturing process involves alcoholic trans-esterification of crude palm oil followed by distillation.

Table 1: Ingredient specific requirements

Test	Method reference	Acceptance criteria
Description
Appearance	Visual	Current: None Proposed: Amber coloured oily liquid
Characteristics
Specific gravity	USP<841>	Current: 0.956 Proposed: 0.94-0.97
Moisture	USP<921>	Current: Not more than 1% Proposed: Not more than 1%
Identification
Tocotrienols complex - palm	HPLC	Current: None Proposed: Complies with the chromatogram for the authenticated reference materials
Assay
Phyto-tocotrienols complex	HPLC	Current: Not less than 50% Proposed: 30–50%1
Alpha-tocopherol	HPLC	Current: 10–14% Proposed: 6–18%
Alpha-tocotrienol	HPLC	Current: 10–14% Proposed: 6–17%
Beta-tocotrienol	HPLC	Current: None Proposed: 0.3–2.0%
Gamma-tocotrienol	HPLC	Current: 20–24% Proposed: 6–24%
Delta-tocotrienol	HPLC	Current: 5–7% Proposed: 1–9%
Monoglycerides/diglycerides/ triglycerides	GC	Current: 34.5% Proposed: 10–70%
Phytosterol complex	GC	Current: 4.0% Proposed: 3–12%
Palm squalene	GC	Current: 8–12% Proposed: 2–15%

Notes

1. 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	Current: None Proposed: Complies
Incidental metals and non-metals
Heavy metals (as lead)	BP (Appendix VII)	Current: Not more than 20 ppm Proposed: Not more than 20 ppm
Pesticide residues and environmental contaminants (including agricultural and veterinary substances)
Pesticide residues	Ph Eur method 2.8.13	Current: None Proposed: Complies
Other organic or inorganic impurities or toxins
Peroxide value	BP (Appendix X F)	Current: Not more than 5 Proposed: 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