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Name of the ingredient
Squid oil (ABN)
Definition of the ingredient
Purified, winterised and deodorised fatty oil obtained from the body of squid (species of order Teuthida, class Cephalopoda). Suitable antioxidants may be added.
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Appearance | Visual | Pale yellow clear liquid |
| Characteristics | ||
| Solubility | BP (General notice) | Practically insoluble in water, very soluble in acetone and in heptane, slightly soluble in anhydrous ethanol |
| Absorbance | Ph Eur method 2.2.25 | Not more than 0.50 at 233 nm |
| Identification | ||
| EPA and DHA | Ph Eur method 2.4.29 | The peaks due to EPA and DHA methyl esters in the chromatogram obtained with test solution (a) match the retention times of the corresponding peaks in the chromatograms obtained with reference solution (a1) and reference solution (a2) |
| Composition of fatty acids | Ph Eur method 2.4.29 | The fatty acids profile obtained from the chromatogram of the sample is similar to that obtained in the chromatogram of the reference standard1 |
| Assay | ||
| EPA as triglycerides | Ph Eur method 2.4.29 | Not less than 9.0 % w/w |
| DHA as triglycerides | Ph Eur method 2.4.29 | Not less than 18.0 % w/w |
| Total omega-3 acids as triglycerides | Ph Eur method 2.4.29 | Not less than 30.0 % w/w |
| Notes | ||
|
||
| Test | Method reference | Acceptance criteria |
|---|---|---|
| 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 | ||
| Dioxins, furans and polychlorinated biphenyls (PCBs) | USP monograph for 'Fish oil containing Omega-3 Acids' | Complies |
| Acid value | Ph Eur method 2.5.1 | Not more than 1.5 |
| Anisidine value | Ph Eur method 2.5.36 | Not more than 15.0 |
| Unsaponifiable matter | Ph Eur method 2.5.7 | Not more than 5.0 % w/w |
| Peroxide value | Ph Eur method 2.5.5 (Method A) | Not more than 5.0 |
| Oligomers | Ph Eur method 2.2.302 | Not more than 1.5% |
| Stearin | AOCS Method Cc11-53 | 10 mL remains clear after cooling at 0°C for 3 h |
| Incidental metals and non-metals | ||
| While ingredient manufacturers are encouraged to include limits for Incidental metals and non-metals, it is the product into which those substances are formulated that contains the ingredient, alone or in combination with other ingredients, must comply with the acceptance criteria set in the United States Pharmacopeia - National Formulary (USP-NF) general chapter ‘<2232> Elemental Contaminants in Dietary Supplements’. When testing is performed at the raw material stage, calculation of the total daily exposure in the finished product should be performed. This calculation is based on the quantity of each ingredient present in the product, the maximum potential contamination given the proposed limits for each raw material and the daily dose of the product. | ||
| 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. | ||
| Notes | ||
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Key to abbreviations
AOCS = American Oil Chemist's Society
BP = British Pharmacopoeia
DHA = Docosahexaenoic acid
EPA = Eicosapentaenoic acid
Ph Eur = European Pharmacopoeia
USP = United States Pharmacopeia