TABLE 3.
Specifications of the NF.
| Description: LNFP‐I/2’‐FL is a white to off‐white powder produced by microbial fermentation and further isolated, purified and concentrated | |
|---|---|
| Source: A genetically modified strain (Escherichia coli K‐12 DH1 MDO MP2173b) of E. coli K‐12 DH1 (DSM 4235) | |
| Parameter | Specification |
| Composition | |
| Specified saccharides a (% w/w DM) | ≥ 90.0 |
| LNFP‐I and 2’‐FL (% w/w DM) | 75.0–100.0 |
| LNFP‐I (% w/w DM) | 50.0–75.0 |
| 2’‐FL (% w/w DM) | 15.0–35.0 |
| LNT (% w/w) | ≤ 5.0 |
| 3‐FL (% w/w) | ≤ 1.0 |
| Sum of l‐fucose and 2′‐fucosyl‐lactitol b (% w/w) | ≤ 1.0 |
| d‐Lactose (% w/w) | ≤ 10.0 |
| DFL (% w/w) | ≤ 2.0 |
| LNFP‐I fructose isomer (% w/w) | ≤ 1.5 |
| 2′‐fucosyl‐d‐lactulose (% w/w) | ≤ 1.0 |
| Sum of other carbohydrates | ≤ 6.0 |
| pH (5% solution, 20°C) | 4.0–7.0 |
| Water (% w/w) | ≤ 8.0 |
| Ash (% w/w) | ≤ 0.5 |
| Protein (% w/w) | ≤ 0.01 |
| Contaminants | |
| Arsenic (mg/kg) | ≤ 0.2 |
| Cadmium (mg/kg) | ≤ 0.1 |
| Lead (mg/kg) | ≤ 0.02 |
| Mercury (mg/kg) | ≤ 0.1 |
| Aflatoxin M1 (μg/kg) | ≤ 0.025 |
| Microbial parameters | |
| Total plate count (CFU/g) | ≤ 1,000 |
| Yeasts and moulds (CFU/g) | ≤ 100 |
| Enterobacteriaceae (in 10 g) | ND |
| Salmonella (in 25 g) | ND |
| Cronobacter spp. (in 10 g) | ND |
| Listeria monocytogenes (in 25 g) | ND |
| Presumptive Bacillus cereus (CFU/g) | ≤ 50 |
| Endotoxins (EU/mg) | ≤ 10 |
Abbreviations: 2’‐FL: 2′‐Fucosyllactose; 3‐FL: 3‐Fucosyllactose; CFU: Colony forming units; DFL: Difucosyllactose; EU: Endotoxin units; LNFP‐I: Lacto‐N‐fucopentaose I; LNT: Lacto‐N‐tetraose; ND: Not detected.
a
Specified saccharides include LNFP‐I, 2’‐FL, LNT, DFL, 3‐FL, d‐lactose, l‐fucose and 2′‐fucosyl‐lactitol, LNFP‐I fructose isomer and 2′‐fucosyl‐d‐lactulose.
b
l‐Fucose and 2′‐fucosyl‐lactitol peaks on the HPAEC–PAD chromatogram overlap.