AMCAL Glucosamine Plus Wild Krill, Sigma Healthcare Limited, CON-301
Product name
AMCAL Glucosamine Plus Wild Krill
Sponsor name
Sigma Healthcare Limited
ARTG
223640
Consent start
Consent no.
CON-301
Standard
United States Pharmacopeia-National Formulary (USP41-NF36) monograph for Krill Oil
Non-compliance with standard
The products do not comply with the of the United States Pharmacopeia-National
Formulary (USP41-NF36) monograph for Krill Oil (Euphausia superba oil; referred
to hereinafter as 'raw material') used in the manufacture of theproducts.
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
belowTable 1 Imposed limits for Krill oil raw materialTestLimits1.Identification
test A-Fatty acid profile Myristic acid5.0-13.0%Oleic
acid6.0-14.5%Eicosapentanoic acid14.0-28.0%2.Ratio between fatty acids Palmitic
acid and myristic acid1.6-3.6%3.Content of AstraxanthinAstraxanthinNot less than
0.005%4.Content of total lipidsSum of Sum of phosphatidylcholine,
1-lysophosphatidylcholine, and 2-lysophosphatidylcholine-60-90%The above limits
are consistent with the proposed revision in the Second Supplement to USP41-NF36
monograph for Krill oil.
Therapeutic product type
Listed complementary medicines