Description/Definition
Lacto-N-fucopentaose I (LNFP-I) and 2’-fucosyllactose (2’-FL) mixture is a purified carbohydrate powder or agglomerate obtained from microbial fermentation with a genetically modified strain of Escherichia coli K-12 DH1 containing at least 75% of LNFP-I and 2’-FL of dry matter, where ≥ 50% is LNFP-I (dry weight) and ≥ 15% is 2’-FL (dry weight).
Characteristics/Composition
Appearance: Powder, agglomerates, powder with agglomerates
Colour: White to off-white
Assay (water-free) Specified saccharides (includes LNFP-I, 2’-FL, lacto-N-tetraose, difucosyl-D-lactose, 3-fucosyllactose, D-lactose, L-fucose and 2’-fucosyl-lactitol, LNFP-I fructose isomer, and 2’-fucosyl-D-lactulose): ≥ 90.0 % (w/w)
Assay (water-free) – LNFP-I and 2’-FL: ≥ 75.0 % (w/w)
Assay (water-free) – LNFP-I: ≥ 50.0 % (w/w)
Assay (water-free) – 2’-FL: ≥ 15.0 % (w/w)
Lacto-N-tetraose: ≤ 5.0 % (w/w)
3-Fucosyllactose: ≤ 1.0 % (w/w)
Sum of L-Fucose and 2’-fucosyl-lactitol: ≤ 1.0 % (w/w)
D-Lactose: ≤ 10.0 % (w/w)
Difucosyl-D-lactose: ≤ 2.0 % (w/w)
LNFP-I fructose isomer: ≤ 1.5 % (w/w)
2’-Fucosyl-D-lactulose: ≤ 1.0 % (w/w)
Sum of other carbohydrates: ≤ 6.0 % (w/w)
pH in 5% solution (20°C): 4.0–7.0
Water: ≤ 8.0 % (w/w)
Ash, sulphated: ≤ 0.5 % (w/w)
Residual protein by Bradford assay: ≤ 0.01 % (w/w)
Heavy metals
Arsenic: ≤ 0.2 mg/kg
Mycotoxins
Residual endotoxins: ≤ 10 EU/mg
Aflatoxin M1: ≤ 0.025 µg/kg
Microbiological criteria
Aerobic mesophilic total plate count: ≤ 1000 CFU/g
Enterobacteriaceae: Absent in 10g
Salmonella spp.: Absent in 25 g
Yeasts: ≤ 100 CFU/g
Moulds: ≤ 100 CFU/g
Bacillus cereus: ≤ 50 CFU/g
Listeria monocytogenes: Absent in 25g
Cronobacter spp.: Absent in 10g
EU: Endotoxin Units
CFU: Colony Forming Units”.
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