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Tocotrienols complex - palm: Proposed revision of draft compositional guideline

18 April 2013

This consultation closed on 19 December 2012. Submissions received and TGA's responses are now available.

Please note that a further revision is open for an additional round of consultation.

At the request of industry, the TGA revised a number of parameters included in the draft compositional guideline for tocotrienols complex - palm and sought comments on the proposed revision of the draft guideline from stakeholders.

A number of the method references and acceptance criteria have been revised and these proposed changes are presented together with the current specifications.

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

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Content last updated: Thursday, 18 April 2013

Content last reviewed: Thursday, 18 April 2013

Web page last updated: Friday, 19 April 2013

URL: http://www.tga.gov.au/newsroom/consult-cm-cg-draft-tocotrienols-complex-palm-121107.htm