Division Specifications:
United Kingdom
| Parameter | Specifications |
|---|---|
| Description | white to off-white crystalline powder |
| pH (20 °C, 5 % solution) | 1,7 – 2,5 |
| N-Acetyl-D-neuraminic acid (dihydrate) | > 97,0 % |
| Water (dihydrate calculates to 10,4 %) | ≤ 12,5 % (w/w) |
| Ash, sulfated | < 0,2 % (w/w) |
| Acetic acid (as free acid and/or sodium acetate) | < 0,5 % (w/w) |
| Heavy Metals | |
| Iron | < 20,0 mg/kg |
| Lead | < 0,1 mg/kg |
| Residual proteins | < 0,01 % (w/w) |
| Residual solvents | |
| 2-Propanol | < 0,1 % (w/w) |
| Acetone | < 0,1 % (w/w) |
| Ethyl acetate | < 0,1 % (w/w) |
| Microbiological specifications | |
| Salmonella | Absent in 25 g |
| Aerobic mesophilic total count | < 500 CFU/g |
| Enterobacteriaceae | Absent in 10 g |
| Cronobacter (Enterobacter) sakazakii | Absent in 10 g |
| Listeria monocytogenes | Absent in 25 g |
| Bacillus cereus | < 50 CFU/g |
| Yeasts | < 10 CFU/g |
| Moulds | < 10 CFU/g |
| Residual endotoxins | < 10 EU/mg |
CFU: Colony Forming Units; EU: Endotoxin Units.