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Compositional guideline: 2'-Fucosyllactose

13 July 2021

Name of the ingredient

2'-Fucosyllactose (AAN)

Definition of the ingredient

Source: 2'-FL is produced with the help of a genetically modified strain of Escherichia coli K12 using fermentation in contained use, then separated from the fermentation broth, filtered and purified by Ion-exchange (optional) and by crystallization. The product can finally be spray-dried to get an amorphous product.

Chemical name: O-6-Deoxy-alpha-L-galactopyranosyl-(1-2)-beta-d-galactopyranosyl-(1-4)-d-glucose

Molecular formula: C18H32O15

CAS Number: 41263-94-9

Table 1. Ingredient specific requirements
Test Method reference Acceptance criteria
Description
Appearance, visual ISO 6658 Powder or agglomerates
Colour, visual ISO 6658 white to off-white
Characteristics
pH (20°C, 5% solution) Ph. Eur. 2.2.3 3.2 – 7.5
Water Karl-Fischer (Ph. Eur. 2.5.12) ≤ 7.0 % (weight)
Identification
Identification, HPLC, Rt main component HPLC Retention time of the sample corresponds with the retention time of the reference standard
Specific optical rotation Method as stated in the Ph. Eur. monograph Lactose monohydrate -55° to -62°
Assay
2'-fucosyllactose HPLC 94.0 - 102.0 % (water-free)
Table 2. Incidental constituents
Test Method reference Acceptance criteria
Residual solvents
Acetic acid (as free acid and/or sodium acetate) Boehringer Mannheim/R-Biopharm Test Kit, Cat. No. 10 148 261 035 (UV method) ≤ 0.5 %
Incidental metals and non-metals
Lead ICP-MS ≤ 0.05 mg/kg
Cadmium ICP-MS ≤ 0.01 mg/kg
Mercury ICP-MS ≤ 0.02 mg/kg
Arsenic ICP-MS ≤ 0.1 mg/kg
Aluminium ICP-MS ≤ 2 mg/kg
Molybdenum ICP-MS ≤ 300 mg/kg
Selenium ICP-MS ≤ 15 mg/kg
Other organic or inorganic impurities or toxins
Residual Endotoxin Limulus amebocyte lysate kinetic chromogenic assay (Ph. Eur. 2.6.14) ≤ 10 EU/mg
Residual Protein Modified Bradford Assay (Roti®-Nanoquant Protein quantitation assay K 880, Carl Roth GmbH) ≤ 0.01 %
D-lactose HPLC ≤ 3.0 % (water free)
L-fucose HPLC ≤ 2.0 % (water free)
3,2'-difucosyl-D-lactose HPLC ≤ 2.0 % (water free)
2'-fucosyl-D-lactulose HPLC ≤ 1.0 % (water free)
Other carbohydrates
(3'-fucosyllactose, fucosylgalactose and others)
HPLC ≤ 1.0 % (water free)
Sulfated ash Ph. Eur. 2.4.14 ≤ 1.5 %

Key to abbreviations

Ph. Eur. = European Pharmacopoeia

HPLC = High-pressure liquid chromatography

ISO = ISO standard method

ICP-MS = Inductively coupled plasma mass spectrometry

Rt = Retention time