Name of the ingredient
Calanus finmarchicus oil (ABN)
Definition of the ingredient
Calanus finmarchicus oil consists primarily of wax esters (>85%) with minor amounts of Eicosapentaenoic acid (EPA), Docosahexaenoic acid (DHA) and Stearidonic acid (SDA).
Calanus finmarchicus oil is extracted from the wild marine zooplankton Calanus finmarchicus. Ground material is suspended in the presence of protease enzyme. The oil fraction is isolated by repeated tricantation. The crude oil is purified by conventional techniques such as evaporation and filtration.
Calanus finmarchicus oil is packed under an inert (N2) atmosphere and stored in the dark at temperatures below 25°C.
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
|
Appearance |
Visual |
Ruby, slightly viscous oil |
|
Odour |
Olfactory |
Light shellfish odour |
| Characteristics | ||
|
Water content |
ISO 8534:20171 |
< 1% |
| Identification | ||
| Chromatograms obtained in the assay for wax esters | AOCS Ch 8-022 | Conforms with the chromatographic fingerprint obtained for an authenticated reference sample |
| Assay | ||
| Wax esters | AOCS Ch 8-022 | >85 % |
| Total fatty acids | GC-FID3 | >46 % |
| Eicosapentaenoic acid (EPA) | GC-FID3 | >3 % |
|
Docosahexaenoic acid (DHA) |
GC-FID3 |
>4 % |
|
Stearidonic acid (SDA) |
GC-FID3 |
>4 % |
|
Total fatty alcohols |
GC-FID3 |
>28 % |
|
C20:1 n-9 fatty alcohol |
GC-FID3 |
>9 % |
|
C22:1 n-11 fatty alcohol |
GC-FID3 |
>12 % |
|
Astaxanthin |
Modified USP-NF4 |
600 – 2600 mg/kg |
| Test | Method reference | Acceptance criteria |
|---|---|---|
|
Incidental metals and non-metals |
||
|
Total Arsenic |
USP <233> |
<14 mg/kg |
|
Inorganic arsenic |
USP <233> |
≤0.1 mg/kg |
|
Cadmium |
USP <233> |
<1 mg/kg |
|
Lead |
USP <233> |
<0.1 mg/kg |
|
Mercury |
USP <233> |
<0.1 mg/kg |
|
Other organic or inorganic impurities or toxins |
||
|
Peroxide Value |
AOCS Cd 8b-905 |
<3 meq. O2/kg |
|
Acid value |
AOCS Ca 5a-406 |
≤ 45 mg KOH/g |
|
Sum of dioxins (WHO-PCDD/F-TEQ) |
EC Reg 644+771/20177 |
<1.75 pg/g |
|
Sum of dioxins and dioxin-like PCBs (WHO-PCDD/F-PCB-TEQ) |
EC Reg 644+771/20177 |
<4 pg/g |
|
Sum PCB28, PCB52, PCB101, PCB138, PCB153, PCB180 (ICES-6) |
EC Reg 644+771/20177 |
<200 ng/g |
|
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. 100 '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 11 of the Order. |
||
Footnotes
| [1] |
ISO 8534:2017: Using Karl Fisher apparatus and a reagent which is free of pyridine |
|---|---|
| [2] |
AOCS Ch 8-02: Capillary column (8-12 m length, 0.25-0.32 mm id and 010-0.30 μm film thickness; Injection volume: 0.5 -1 μL; Hydrogen carrier gas: 20-35 cm/sec; Column temperature: 80°C at first, ramping at 20°C/min to 240°C, then programmed to increase by 5°C/min to 325°C, then ramping at 20°C /min, up to 340°C; Detector temperature: 350°C |
| [3] | GC-FID: Derivatisation by acid methylation (Methanol+H2SO4). Results quantified by GC-FID analysis with internal standard of FA 21:0. GC-FID: Column: Phenomenex WaxPluss column (30 m x 0.25 mm id and 0.25 μm film thickness; Injection volume: 1 μL in splitless mode; Helium carrier gas: 1.2 mL/min; Column temperature: 70°C for 0.6 min, 70-170°C (25°C/min), 170-235°C (3°C/min), 235-255°C (15°C/min); Detector temperature: 270°C; Injector temperature: 220°C |
| [4] | Modified USP-NF: Modified method as per that in the USP-NF for astaxanthin ester monograph |
| [5] | AOCS Cd 8b-90: Titration method determining all substances in terms of milliequivalents of peroxide per 1000 grams of sample, that oxidised potassium iodide. Titrated with sodium thiosulfate. 10% SDS and starch solution added during titration. |
| [6] | AOCS Ca 5a-40: Titration method using hot neutralised alcohol and indicator. Titrated with sodium hydroxide. The acid value is the number of milligrams of KOH necessary to neutralise 1 g of sample. |
| [7] | EC Reg 644+771/2017: Apply confirmatory methods using analysis by means of gas chromatography/high resolution mass spectrometry (GC-HRMS) or gas chromatography/tandem mass spectrometry (GC-MS/MS). Quantification with suitable internal standards or isotope-labelled internal standards. |
Key to abbreviations:
AOCS = The American Oil Chemists’ Society
DIN EN = Deutches Institute fur Normung Europaische Norm
EC Reg = Council Regulation (EEC)
GC-FID = Gas Chromatography Flame Ionisation Detector
HPLC = High-pressure Liquid Chromatography
ICES = International Conference on Establishment Statistics
ISO – International Standardization Organisation
PCBs = Polychlorinated biphenyls
Ph. Eur = European Pharmacopoeia
WHO-PCDD = World Health Organisation polychlorinated dibenzo-para-dioxins
F-TEQ = Toxic equivalent
USP-NF = United States Pharmacopoeia – National Formulary