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Compositional guideline: DHA/EPA rich Schizochytrium algal oil

5 March 2014

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. 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:
  • Palmitic acid (16:0)
Ph Eur method 2.4.29 15.0 - 25.0%
  • EPA (20:5 n-3)
Ph Eur method 2.4.29 Not less than 14.0%
  • DPA (22:5 n-3)
Ph Eur method 2.4.29 2.0 - 7.0%
  • DHA (22:6 n-3)
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

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Content last updated: Wednesday, 5 March 2014

Content last reviewed: Wednesday, 5 March 2014

Web page last updated: Wednesday, 5 March 2014

URL: http://www.tga.gov.au/industry/cm-cg-dha-epa-rich-schizochytrium-algal-oil.htm