ANNEX ISupplementary provisions
ANNEX I SPECIFICATION OF LACTO- N -NEOTETRAOSE Definition: Chemical name β-d-Galactopyranosyl-(1→4)-2-acetamido-2-deoxy-β-d-glucopyranosyl-(1→3)-β-d-galactopyranosyl-(1→4)-d-glucopyranose Chemical formula C 26 H 45 NO 21 Molecular weight 707,63 g/mol CAS No 13007-32-4 Description: Lacto- N -neotetraose is a white to off-white powder. Purity: Test Specification Assay Not less than 96 % D-Lactose Not more than 1,0 w/w % Lacto-N-triose II Not more than 0,3 w/w % Lacto-N-neotetraose fructose isomer Not more than 0,6 w/w % pH (20 °C, 5 % solution) 5,0-7,0 Water (%) Not more than 9,0 % Ash, sulphated Not more than 0,4 % Acetic acid Not more than 0,3 % Residual solvents (methanol, 2-propanol, methyl acetate, acetone) Not more than 50 mg/kg singly Not more than 200 mg/kg in combination Residual proteins Not more than 0,01 % Palladium Not more than 0,1 mg/kg Nickel Not more than 3,0 mg/kg Microbiological criteria: Aerobic mesophilic bacteria total count Not more than 500 CFU/g Yeasts Not more than 10 CFU/g Moulds Not more than 10 CFU/g Residual endotoxins Not more than 10 EU/mg