Nature's Own Ultra Krill Oil 1000mg, Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare, CON-284
Product name
Nature's Own Ultra Krill Oil 1000mg
Sponsor name
Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare
Consent start
Consent no.
CON-284
Standard
The 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) eicosapentaenoic acid (C20#58;5 n-3) and palmitoleic acid
(C16#58;1 n-7) 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%
Eicosapentaenoic acid
14.0-28.0%
Palmitoleic acid
2.5-12.0%
Ratio between fatty acids
Palmitic acid and myristic acid
1.6-3.6%
Content of Astaxanthin
Astaxanthin
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 USP40-NF35 and all other
applicable standards
Therapeutic product type
Listed complementary medicines