Table 3.
Specifications of the NF
| Description: 6′‐sialyllactose sodium salt is a white to off‐white powder produced by microbial fermentation and further isolated, purified and concentrated. | |
| Source: A genetically modified strain (Escherichia coli NEO6) of E. coli W (ATCC 9637). | |
| Parameter | Specification |
| Composition | |
| 6′‐SL sodium salt (% w/w DM) | ≥ 82.0 |
| Sialic acid (% w/w DM) | ≤ 6.0 |
| d‐Lactose (% w/w DM) | ≤ 3.0 |
| d‐Glucose (% w/w DM) | ≤ 3.0 |
| Sum of 6′‐sialyllactulose and 3′‐SL sodium salts (a) (% w/w DM) | ≤ 5.0 |
| Sum of other carbohydrates (b) (% w/w DM) | ≤ 13.0 |
| Water (% w/w) | ≤ 10.5 |
| Protein (% w/w) | ≤ 0.01 |
| pH (5% solution, 25°C) | 4.5–7.5 |
| Sodium (% w/w DM) | ≤ 5.0 |
| Contaminants | |
| Arsenic (mg/kg) | ≤ 0.2 |
| Aflatoxin M1 (μg/kg) | ≤ 0.025 |
| Microbiological 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 |
6′‐SL: 6′‐Sialyllactose; 3′‐SL: 3′‐Sialyllactose; CFU: Colony forming units; DM: Dry matter; EU: Endotoxin units; ND: Not detected; w/w: Weight per weight.
(a)
6′‐sialyllactulose and 3′‐SL sodium salts peaks on the HPLC‐CAD chromatograms overlap.
(b)
Sum of other carbohydrates = 100% w/w DM – 6′‐SL (acid) (% w/w DM) – quantified carbohydrates (i.e., sialic acid, d‐glucose, d‐lactose, 6′‐sialyllactulose (acid) and 3′‐SL (acid); % w/w DM) – sodium (% w/w DM).