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Refined Buglossoides arvensis seed oil

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Name of the ingredient

Refined Buglossoides arvensis seed oil. 

Definition of the ingredient

Refined Buglossoides arvensis seed oil is a refined triglyceride oil derived from the seeds of Buglossoides arvensis in which the polyunsaturated fatty acids, alpha-linolenic acid (44%), stearidonic acid (20%), and linoleic acid (13%) are the main fatty acids, with smaller amounts of oleic acid, gamma-linolenic acid, and saturated fatty acids. The substance is manufactured through either a cold press process or by solvent extraction.
 

Table 1.    Ingredient specific requirements

Test

Method reference

Acceptance criteria

Description

Appearance

Visual

Pale Yellow Liquid

Odour

Organoleptic

Characteristic

Color

AOCS Cc 13j-97

<2.0 R; <20.0 Y

Characteristics

Moisture and volatiles

AOCS Ca 2e-84

<0.2%

Solubility in water

Visual

Insoluble

Refractive index

AOCS Cc 7-25

1.4860 @ 20°C

Specific gravity

AOCS Cc 1a-64

0.9337 @ 20°C

Viscosity

AOCS Tq 1a-64

42-49 cps

Flash point

AOCS Cc 9b-55

180-190°C

Melamine

FDA LIB 4422

<0.05 mg/Kg

Cyanuric acid

FDA LIB 4422

<0.25 mg/Kg

Tocopherol and tocotrienol

DGF F-II 4a

250-550 mg/Kg

Identification

Genetic and taxonomic validation of seeds and plants

Seed genetics, morphology, AHP voucher specimen

Pass >98% purity

Fatty acid composition

AOCS Ce 1h-05

All levels must be in range simultaneously:

Stearidonic acid (c18:4n-3) 17-21%
alpha-Linolenic acid (c18:3n-3) 42-48%
gamma-Linolenic acid (c18:3n-6) 4.5-8%
Linoleic acid (c18:2n-6) 9-15%
Palmitic acid (c16:0) 4-7%
Oleic acid (c18:1n-9) 6-14%

Assay

Trans fatty acids

AOCS Ce 1h-05

Not more than 2.0% (w/w) of total fatty acids

Acid value

AOCS Cd 3d-63

Not more than 0.6 mg KOH/g

Free Fatty Acids

AOCS Ca 5a-40

Not more than 0.3%

Oxidative Stability Index

AOCS Cd 12b-92

30-34 hrs @ 75°C

Glycerol

AOCS Cd 11c-93

<1.1%

Monoglycerides

AOCS Cd 11c-93

<4%

Epoxy fatty acids

AOCS Ce 1h-05

<0.1%

Diglycerides

AOCS Cd 11c-93

>2% - <9%

Triglycerides

AOCS Cd 11c-93

>89% - <99%

Sterols

ISO 12228

<5000 mg/Kg

Peroxide value (PV)

AOCS Cd 8-53

Not more than 5 mEq/Kg

p-Anisidine value (p-AnV)

AOCS Cd 18-90

Not more than 15

TOTOX value

2PV + p-AnV

Not more than 20

Unsaponifiable content

AOCS Ca 6a-40

Not more than 1.5%

Protein content

CBQCA Protein quantification kit[1]

Not more than 10 µg/mL

Pyrrolizidine alkaloids

HPLC-MS[2]

Not detectable with a detection limit of 1 µg/Kg 

Erucic acid

AOCS Ce 1h-05

Not more than 1.0%

Iodine value

AOCS Cd 1c-85

210-250 cg/g

Cold Test

AOCS Cc 11-53

>5.5 hr @ 0°C

Table 2.     Incidental constituents

Test

Method reference

Acceptance criteria

Residual Solvents

Hexane

AOCS Ca 3b-87

<1 mg/Kg

Incidental metals and non-metals

Lead

AOAC 993.14 / ICP-MS

Not more than 0.1 ppm

Arsenic

AOAC 993.14 / ICP-MS

Not more than 0.1 ppm

Cadmium

AOAC 993.14 / ICP-MS

Not more than 0.1 ppm

Mercury

AOAC 993.14 / ICP-MS

Not more than 0.1 ppm

Pesticide residues and environmental contaminants: (including agricultural and veterinary substances)

Pesticides

Ph. Eur. 2.8.13;

AOAC 2007.01

No detection

Other organic impurities or toxins

Sum of dioxins

WHO-PCDD/F-TEQ[3]

Not more than 0.75 pg/g

PCBs (209 congeners)

US EPA 1668

Not more than 0.09 mg/Kg

WHO-12 PCBs + ICES6 PCBs (Sum of PCB congeners 28, 52, 101, 138, 153, 180)

FDA PAM 304 E3C5

Not more than 40 ng/g

PAHs

GC-MS

<2.0 ug/Kg for benzo(a)pyrene

<10 ug/Kg for total PAHs (i.e., sum of benzo(a)pyrene, benzo(a)anthracene, benzo(b)fluoranthene, and chrysene)

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. Rigby, N.M., Sancho, A.I., Salt, L.J., Foxall, R., Taylor, S., Raczynski, A., Cochrane, S.A., Crevel, R.W. and Mills, E.C., 2011. Quantification and partial characterization of the residual protein in fully and partially refined commercial soybean oils. Journal of agricultural and food chemistry, 59(5), pp.1752-1759.
  2. Cramer, L., Schiebel, H.M., Ernst, L. and Beuerle, T., 2013. Pyrrolizidine alkaloids in the food chain: development, validation, and application of a new HPLC-ESI-MS/MS sum parameter method. Journal of agricultural and food chemistry, 61(47), pp.11382-11391.
  3. The sum of the toxic equivalencies of the 17 most toxicologically significant dioxins and furans.

Key to abbreviations:

AHP = American Herbal Pharmacopoeia
AOAC = Association of official agricultural chemists
BP = British pharmacopoeia
CBQCA = 3-(4-Carboxybenzoyl)quinoline-2-carboxaldehyde
cps = Centipoise
DGF = German standard (oil and fat analysis)
FDA PAM = United States Food and drug administration - Pesticide Analytical Manual
FDA LIB = United States Food and drug administration - Laboratory information bulletin
GC = Gas chromatography
hr = Hours
HPLC = High pressure liquid chromatography
HPTLC = High performance thin layer chromatography
ICES = International council for the exploration of the sea
ICP = Inductively coupled plasma
IR = Infrared spectrophotometry
ISO = International organisation for standardisation
mEq = Milliequivalent
MS = Mass spectrometry
PAHs = Polycyclic aromatic hydrocarbons
PCBs = Polychlorinated biphenyls
PCDD = Polychlorinated dibenzodioxin
Ph. Eur. = European pharmacopoeia
ppm = Parts per million
TEQ = Toxic equivalency factor
TOTOX value = Total oxidation value
US EPA = United States Environmental protection agency
USP = United States pharmacopoeia
WHO = World health organisation

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