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KRILL OIL METAGENICS, Metagenics (Aust) Pty Ltd, CON-290
Product name
KRILL OIL METAGENICS
Sponsor name
Metagenics (Aust) Pty Ltd
ARTG
269032
Consent start
Consent no.
CON-290
Standard
United States Pharmacopeia-National Formulary (USP41-NF36) monograph for Krill Oil.
Non-compliance with standard
The raw material complies with the USP41-NF36 monograph, with the exception
of#58; The concentrations of the fatty acids myristic acid (C14#58;0), oleic
acid (C18#58;1 n-9) and eicosapentoenoic acid (C20#58;5 n-3) in the acceptance
criteria for 'Identification Test A-Fatty Acid Profile' The ratio between
palmitic acid (C16#58;0) and myristic acid (C14#58;0) in the acceptance criteria
for 'Identification Test A-Fatty Acid Profile' The acceptance criteria 'Content
of Astaxanthin'
Conditions imposed
Consent is given to import and supply the raw material and the products on
the condition that the raw material meets the limits as set out in the table
below#58;
Table 1#58; Imposed limits for Krill oil raw material
Test
Limits
Identification test A-Fatty acid profile
Myristic acid
5.0-13.0%
Oleic acid
6.0-14.5%
Eicosapentanoic acid
14.0-28.0%
Ratio between fatty acids
Palmitic acid and myristic acid
1.6-3.6%
Content of Astraxanthin
Astraxanthin
Not less than 0.005%
The raw material and products in relation to which the consent is given must
comply with all other applicable parts of the current USP41-NF36 and all other
applicable standards.
Therapeutic product type
Listed complementary medicines