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Name of the ingredient:
Galactooligosaccharides (AAN ID#142918)
Definition of the ingredient
Galactooligosaccharides (GOS) is produced from lactose by an enzymatic process using Β‑galactosidases from Papiliotrema terrestris or Neobacillus kokaensis. A lactase enzyme may be used to reduce the level of residual lactose. The final ingredient can be in powder, syrup, or easy drying syrup forms.
Molecular Formula: (C6H11O5)n
Chemical Structure:
| Test | Method reference | Acceptance criteria |
|---|---|---|
|
Description |
||
|
Appearance |
Visual |
Syrup or powder |
|
Colour |
Visual |
Clear (for syrup forms) White (for powder form) |
|
Characteristics |
||
|
Dry matter (for syrup forms only) |
ISO 6734/IDF 15 |
74 to 76% |
|
Total moisture (for powder form only) |
ISO 760, Karl Fischer |
≤4% |
|
Sulfated ash |
NEN 6810; NEN-EN-ISO 5809 |
≤1.0% (on dry matter) |
|
Nitrogen |
ISO 8968-2/IDF 20-2 Kjeldahl |
≤0.1% |
|
Nitrite |
ISO 14673-2/IDF 189-2 |
≤2 mg/Kg |
|
pH (10% solution at 20°C) |
NEN 3775 |
2.8 to 4.5 |
|
Identification |
||
|
HPAEC-PAD |
van Leeuwen et al., 2016[1] |
Retention time of the main peak corresponds to the retention time of the GOS standard. |
|
NMR |
van Leeuwen et al., 2016[1] |
Recorded 1H NMR spectrum must be in full agreement with the structure of GOS. |
|
MALDI-TOF-MS |
van Leeuwen et al., 2016[1] |
Spectra must conform to the GOS standard. |
|
Assay |
||
|
Galactooligosaccharides (GOS)[2] |
HPAEC-PAD[3] |
≥57% (on dry matter) |
|
Lactose |
HPAEC-PAD[3] |
≤30 % (on dry matter) |
|
Glucose |
HPAEC-PAD[3] |
≤22% (on dry matter) |
|
Galactose |
HPAEC-PAD[3] |
≤2.5% (on dry matter) |
|
Glucose + Galactose (for powder forms only) |
HPAEC-PAD[3] |
≤7% (on dry matter) |
| Test | Method reference | Acceptance criteria |
|---|---|---|
|
Incidental metals and non-metals |
||
|
Lead |
ISO 17294, ICP-MS |
Max. 0.16 mg/Kg |
|
Arsenic |
ISO 17294, ICP-MS |
Max. 0.1 mg/Kg |
|
Cadmium |
ISO 17294, ICP-MS |
Max. 0.005 mg/Kg |
|
Mercury |
ISO 17294, ICP-MS |
Max. 0.006 mg/Kg |
|
Nickel |
ISO 17294, ICP-MS |
Max. 0.03 mg/Kg |
|
Cobalt |
ISO 17294, ICP-MS |
Max. 0.005 mg/Kg |
|
Vanadium |
ISO 17294, ICP-MS |
Max. 0.005 mg/Kg |
|
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:
- van Leeuwen SS, Kuipers BJ, Dijkhuizen L, Kamerling JP (2016). Comparative structural characterization of 7 commercial galacto-oligosaccharide (GOS) products. Carbohydr Res 425:48-58. DOI:10.1016/j.carres.2016.03.006.
- GOS content is determined by calculation and the equation used is as follows:
GOS wt% = 100% - (lactose wt% + glucose wt% + galactose wt%)
- HPAEC: Columns: Analytical anion exchange column - Thermo Dionex Carbopac SA10 (4 x 250mm), Guard anion exchange column - Thermo Dionex Carbopac SA10 (4 x 50mm); Mobile phase: Eluent A (125 mM sodium hydroxide solution), Eluent B (UHQ Water); Flow rate: 1.00 mL/min; Column temperature: 25°C; Retention times as follows:
|
Component |
Retention time (min) |
|---|---|
|
Galactose |
5.690 |
|
Glucose |
6.250 |
|
Lactose |
8.450 |
Abbreviations
HPAEC-PAD: High performance anion-exchange chromatography coupled with pulsed electrochemical detection
ICP-MS: Inductively coupled plasma coupled with mass spectrometric detection
IDF: International dairy federation
ISO: International organisation for standardisation
MALDI-TOF-MS: Matrix-assisted laser desorption ionisation coupled with time-of-flight mass spectrometric detection
NEN: Nederlandse norm
NMR: Nuclear magnetic resonance spectroscopy