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 | ||
|
||
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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