Name of the ingredient
EPA-rich Nannochloropsis oculata oil
Definition of the ingredient
EPA-rich Nannochloropsis oculata oil is a deodorised, hydrolysed, and winterised Eicosapentaenoic acid (EPA)-rich oil that is derived from the microalgae, Nannochloropsis oculate, originally obtained from a brackish supralittoral rock pool off the coast of Scotland. The oil is composed of 55% total fatty acid, of which >24% is Eicosapentaenoic acid (EPA).
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Appearance and Colour | Visual | Viscous dark green oily paste. Samples are almost black in colour. When spread, a thin green hue is visible. |
| Odour | Organoleptic | The paste has a strong plant-based odour. |
| Characteristics | ||
| Moisture | Karl Fischer | <5% w/w |
| Identification | ||
| Fatty Acid profile |
AOCS Ce 2-66, AOCS Ce 1-62 |
Conforms with the chromatographic fingerprint obtained for an authenticated reference material. |
| Polar lipids profile | 31P-NMR + 1H-NMR[1] | Conforms with the NMR fingerprint obtained for an authenticated reference material. |
| Assay | ||
|
Lipid composition: Total polar lipids Total phospholipids Total glycolipids |
31P-NMR + 1H-NMR[1] 31P-NMR[1] 1H-NMR[1] |
>15.0% (w/w) >4.0% (w/w) >8.0% (w/w) |
|
Fatty Acid profile: Total Omega-3 EPA (C20:5 ω3) EPA/Total Omega-3[2] Total Fatty Acid Assay (TFA) Unsaponifiable matter[3] |
AOCS 996.06 AOCS 996.06 Percentage Calculated AOCS Ca 5b-71 Percentage Calculated |
>24.0% >24.0% >97.0% >55.0% <45.0% |
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Residual solvents | ||
|
Ethanol |
USP <467> |
≤5000 ppm |
| Hexane | USP <467> | ≤290 ppm |
| Incidental metals and non-metals | ||
|
Total Arsenic |
USP <233> |
<0.4 ppm |
| Lead |
USP <233> |
<0.4 ppm |
| Mercury |
USP <233> |
<0.4 ppm |
| Cadmium |
USP <233> |
<0.4 ppm |
| Other organic or inorganic impurities or toxins | ||
| Peroxide value | Modified AOCS Cd 8-53[4] | <5.0 meq/Kg |
| Pheophorbides (as Pheophorbide A) | Reversed Phase HPLC (USP <621>) | <1 mg/g |
| 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. 100 '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 11 of the Order. |
||
Footnotes
| [1] | NMR: 300 mg of the test item and 15 mg of the internal standard (i.e. Triphenyl Phosphate) are exactly weighed and dissolved in 7 mL CDCl3/MeOD/Cs-EDTA-D2O (3:2:2). After shaking for a minimum of 30 minutes, the organic layer is separated by centrifugation. 2 mL of MeOD/Cs-EDTA-D2O (1:1) is further added. After shaking for 15 minutes, the organic layer is again separated by centrifugation and measured (1H-NMR and 31P-NMR). |
|---|---|
| [2] | EPA/Total Omega-3 represents the proportion of EPA (C20:5 ω3) component within the "Total Omega 3" and is calculated according to the following equation:
EPA/Total Omega-3 = EPA (% w/w)/Omega-3 (% w/w) x 100 |
| [3] | Unsaponifiable matter percentage equals 100% minus Total Fatty Acid (TFA) percentage. |
| [4] | After addition of the saturated KI solution, allowing the solution to stand with occasional vigorous shaking for 1 min, and addition of 30 mL of distilled water, the resulting solution is centrifuged at 5000 rpm for 5 min and the resulting upper phase is separated into a clear flask and titrated with the with 0.1N standard sodium thiosulfate solution. |
Key to abbreviations
AOCS = American Oil Chemists' Society
AOAC = Association of Official Agricultural Chemists
EPA = Eicosapentaenoic Acid
HPLC = High Performance Liquid Chromatography
NMR = Nuclear Magnetic Resonance
USP = United States Pharmacopoeia