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Fish oil - natural

Compositional guideline for 'Fish oil - natural' permitted for use in listed medicines

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Name of the ingredient

Fish oil - natural (ABN)

Definition of the ingredient

The substance is the purified fatty oil obtained from fish of families including but not limited to Ammodytidae, Carangidae, Clupeidae, Engraulidae, Osmeridae, Salmonidae1 and Scombridae. Suitable antioxidants may be added.

Table 1. Ingredient specific requirements
Test Method reference Acceptance criteria
Description
Appearance Visual Pale yellow liquid
Odour Organoleptic Fishy
Characteristics
Solubility BP (General notice) Practically insoluble in water, very soluble in acetone and in heptane, slightly soluble in anhydrous ethanol
Identification
Chromatograms obtained in the assay for EPA and DHA Ph Eur method 2.4.29 Complies2
Assay
Sum of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) BP (Appendix X P); Ph Eur method 2.4.29 ≥ 10.0%3
Total omega-3-acids BP (Appendix X P); Ph Eur method 2.4.29 ≥ 14.0%3

Notes:

  1. Where farmed salmon oil is formulated in medicines under the ARTG, it must comply with the BP monograph for Farmed Salmon Oil.
  2. The peaks due to eicosapentaenoic acid methyl ester and docosahexaenoic methyl ester in the chromatogram obtained with test solution (b) match the retention time to the corresponding peaks in the chromatogram obtained with reference solution (a).
  3. Expressed as triglycerides. Assay results should be determined using BP methodology (that is external standards), not relative peak area calculations.
Table 2. Incidental constituents
Test Method reference Acceptance criteria
Residual solvents
Solvent residues Ph Eur method 2.4.24 Complies
Incidental metals and non-metals
Lead Ph Eur method 2.4.27 ≤ 0.5 ppm
Arsenic ≤ 1 ppm
Cadmium ≤ 0.5 ppm
Mercury ≤ 0.5 ppm
Pesticide residues and environmental contaminants:
(including agricultural and veterinary substances)		 Ph Eur method 2.8.13 Complies
Other organic or inorganic impurities or toxins
Oligomers Ph Eur method 2.3.304 ≤ 1.5%
Acid value Ph Eur method 2.5.1 (in 20 g of the oil) ≤ 2.0
Peroxide value Ph Eur method 2.5.5 (Method A) ≤ 10.0
Anisidine value Ph Eur method 2.5.36 ≤ 30.0
Unsaponifiable matter Ph Eur method 2.5.7 (in 5 g of the oil) ≤ 1.5%
Dioxins, furans and polychlorinated biphenyls (PCBs) USP monograph for 'Fish oil containing Omega-3 Acids' Complies
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 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.

Notes:

  1. Using the test method described in the BP monograph for Fish Oil, Rich in Omega-3-Acids.

Additional comments

The TGA recognises the following Fish Oil monographs:

Refined fish oil, namely:

  1. Fish Oil, Rich in Omega-3-Acids (BP) as the official standard applying to fish oils containing minimum 28% total omega-3 acids expressed as triglycerides, and
  2. Farmed Salmon Oil (BP),

and

Reconfigured fish oil, namely, Omega-3-Marine Triglycerides (BP).

The TGA adopted synonym for the material covered in this BP monograph is 'Concentrated Omega-3 triglycerides-fish' (AAN).

All other fish oils that do not meet the definition of the substances that are the subject of the above monographs should meet the specification in the TGA compositional guideline for Fish oil - natural.

Key to abbreviations

BP = British Pharmacopoeia

Ph Eur = European Pharmacopoeia

USP = United States Pharmacopoeia

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