ANNEX ISupplementary provisions
ANNEX I SPECIFICATIONS OF N -ACETYL-D-NEURAMINIC ACID (DIHYDRATE) Definition: Chemical name IUPAC names: N -Acetyl-D-neuraminic acid (dihydrate) 5-Acetamido-3,5-dideoxy-D-glycero-D-galacto-non-2-ulopyranosonic acid (dihydrate), Synonyms: Sialic acid (dihydrate) Chemical formula C 11 H 19 NO 9 (acid) C 11 H 23 NO 11 (C 11 H 19 NO 9 *2H 2 O) (dihydrate) Molecular mass 309,3 Da (acid) 345,3 (309,3 + 36,0) (dihydrate) CAS No. 131-48-6 (free acid) 50795-27-2 (dihydrate) Description: N -Acetyl-D-neuraminic acid is a white to off-white crystalline powder. Specifications: 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.