Swisse Ultiboost Super Strength Deep Sea Krill Oil, Swisse Wellness Pty Ltd, CON-240
Product name
Swisse Ultiboost Super Strength Deep Sea Krill Oil
Sponsor name
Swisse Wellness Pty Ltd
ARTG
292915
Consent start
Consent no.
CON-240
Standard
The United States Pharmacopeia-National Formulary (USP40-NF35) monograph for Krill Oil.
Non-compliance with standard
Non-compliance with The United States Pharmacopeia-National Formulary
(USP40-NF35) monograph for Krill Oil, the default standard for Krill Oil in
Australia. The raw material complies with the USP40-NF35 monograph, with the
exception of#58; 1. 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' 2. 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' 3. The
acceptance criteria 'Content of Astaxanthin'
Conditions imposed
That the raw material meets the limits as set out in the table below#58;
Imposed limits for exempt Krill oil#58;
Test
Limits
1.
Identification Test A-Fatty Acid Profile
Myristic acid
5.0-13.0%
Oleic acid
6.0-14.5%
Eicosapentoenoic acid
14.0-28.0%
Ratio between palmitic and myristic acids
1.6-3.6%
2. Content of Astaxanthin
NLT 0.005%
NLT = Not less than
The raw material 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