Name of the ingredient
DHA/EPA rich Schizochytrium algal oil (AAN)
Definition of the ingredient
'DHA/EPA rich Schizochytrium algal oil' is the winterized, deodorized oil derived from cultivated microalgae 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 (DHA) at not less than 24% w/w and eicosapentaenoic acid (EPA) at not less than 12% w/w, and the ratio of DHA to EPA is 2:1. Suitable antioxidants may be added.
Table 1: Ingredient specific requirements
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Appearance | Visual | Light yellow oil |
| Odour | Organoleptic | Characteristic |
| Characteristics | ||
| Moisture and Volatiles | AOCS Ca 2c - 25 | Not more than 0.02% w/w |
| Identification | ||
| Fatty acid profile | Ph Eur method 2.4.29 | The fatty acid profile is similar to the chromatogram obtained from a authenticated reference material, and meets the requirements below: |
|
Ph Eur method 2.4.29 | 15.0 - 25.0% |
|
Ph Eur method 2.4.29 | Not less than 14.0% |
|
Ph Eur method 2.4.29 | 2.0 - 7.0% |
|
Ph Eur method 2.4.29 | Not less than 28.0% |
| Assay | ||
| DHA (22:6 n-3) as triglycerides | Ph Eur method 2.4.29 | Not less than 240 mg/g |
| EPA (20:5 n-3) as triglycerides | Ph Eur method 2.4.29 | Not less than 120 mg/g |
Table 2: Incidental constituents
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Residual solvents | ||
| Residual solvents | BP (Appendix VIII L and SD IV D) | Complies |
| Incidental metals and non-metals | ||
| Lead | Ph Eur method 2.4.27 | Not more than 0.1 ppm |
| Arsenic | Ph Eur method 2.4.27 | Not more than 0.1 ppm |
| Cadmium | Ph Eur method 2.4.27 | Not more than 0.1 ppm |
| Mercury | Ph Eur method 2.4.27 | Not more than 0.04 ppm |
| Other organic or inorganic impurities or toxins | ||
| Acid Value | Ph Eur method 2.5.1 | Not more than 0.5 |
| Trans Fatty Acids | AOCS Ce 1f - 96 | Not more than 1% w/w |
| Peroxide Value | Ph Eur method 2.5.5 A | Not more than 5 |
| Anisidine Value | Ph Eur method 2.5.36 | Not more than 20 |
| TOTOX | USP (401) | Not more than 26 |
| Unsaponifiable matter | Ph Eur method 2.5.7 | Not more than 4.5% w/w |
| 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
AOCS = American Oil Chemist's Society
BP = British Pharmacopoeia
DHA = Docosahexaenoic acid
DPA = Docosapentaenoic acid
EPA = Eicosapentaenoic acid
Ph Eur = European Pharmacopoeia
USP = United States Pharmacopeia