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Name of the ingredient
Docosahexaenoic acid (DHA) - rich oil derived from microalgae Schizochytrium sp. (AAN)
Definition of the ingredient
DHA-rich oil derived from microalgae Schizochytrium sp. is the winterised, deodorised oil derived from cultivated Schizochytrium sp. Due to taxonomical name changes made to the genus Schizochytrium, and for the purposes of this Compositional Guideline, the following genus and species are considered to be included: Schizochytrium aggregatum, Aurantiochytrium limacinum, Aurantiochytrium mangrovei, Oblongichytrium minutum, Oblongichytrium octosporum.
It contains docosahexaenoic acid at not less than 350 mg/g. Suitable standardising agents and antioxidants may be added.
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Characteristics | ||
| Identification | ||
| Assay | ||
| Appearance | Visual | Semi-solid to liquid oil, yellow–dark orange colour |
| Odour | Organoleptic | Characteristic odour |
| Moisture and volatiles | AOCS Ca 2c - 25 | ≤ 0.05% w/w |
| Fatty acid composition | AOCS Ce 1b - 89 | Complies, matches spectrum of authenticated reference material |
| DHA (22:6 n-3) | AOCS Ce 1b - 89 (GC) | ≥ 350 mg/g |
| Free fatty acids | AOCS Ca 5a - 40 | ≤ 0.25% w/w |
| Trans fatty acids | AOCS Cd 14 - 95 | ≤ 1% w/w |
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Incidental metals and non-metals | ||
| Other organic or inorganic impurities or toxins | ||
| Microbiology | ||
| Lead | AOCS Ca 17 - 01 | ≤ 0.1 ppm |
| Arsenic | AOCS Ca 17 - 01 | ≤ 0.1 ppm |
| Cadmium | AOCS Ca 17 - 01 | ≤ 0.1 ppm |
| Mercury | AOAC 974.14 and 975.15 | ≤ 0.04 ppm |
| Peroxide value | AOCS Cd 8 – 53 | ≤ 5 meq/kg |
| Totox value | USP <401> | ≤ 26 meq/kg |
| Unsaponifiable matter | AOCS Ca 6b - 53 | ≤ 4.5% w/w |
| Nitrogen | AOAC 988.05 | ≤ 0.02% |
| 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 which 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:
AOAC = Association of Analytical Communities
AOCS = American Oil Chemists' Society
GC = Gas chromatography
USP = United States Pharmacopoeia
| Version | Description of change | Author | Effective date |
|---|---|---|---|
| 1.0 | Original publication | Complementary Medicines Evaluation Section | 18/01/2018 |
| 2.0 | Amendment to change the ‘Definition of the ingredient’ to include more information about the genus and species | Complementary Medicines Evaluation Section | 20/12/2010 |
| 2.1 | Minor corrections including alignment of the online version with the PDF version of the CG | Complementary Medicines Evaluation Section | 3/05/2024 |