Parameter Specification Method
2’-FL ≥ 82.0 % w/w DM HPLC-PAD (in-house)
D-lactose ≤ 5.0 % w/w DM HPLC-PAD (in-house)
L-fucose ≤ 1.0 % w/w DM HPLC-PAD (in-house)
D-glucose and D-galactose ≤ 1.0 % w/w DM HPLC-PAD (in-house)
Fucosylgalactose ≤ 3.0 % w/w DM HPLC-PAD (in-house)
Difucosyllactose ≤ 3 % w/w DM HPLC-PAD (in-house)
Sum of other carbohydrates ≤ 8.0 % w/w DM Calculation
Water ≤ 9.0 % w/w JP 2.48
Protein ≤ 0.01 % w/w Bradford assay
Ash ≤ 0.5 % w/w JP 2.44
pH (5% solution, 25oC) 4.5 – 8.5 JP 2.54
Arsenic ≤ 0.2 mg/kg USP <233> or AOAC method
Cadmium ≤ 0.1 mg/kg USP <233> or AOAC method
Lead ≤ 0.02 mg/kg USP <233> or AOAC method
Mercury ≤ 0.1 mg/kg USP <233> or EPA method
Aflatoxin M1 ≤ 0.025 µg/kg AOAC 2000.08
Aerobic plate count ≤ 1,000 CFU/g ISO 4833-1:2013
Yeast and mould ≤ 100 CFU/g ISO 21527-2:2008
Enterobacteriaceae Absent in 10g ISO 21528-1:2017
Salmonella spp. Absent in 25g ISO 6579-1:2017
Cronobacter spp. Absent in 10g ISO 22964:2017
Listeria monocytogenes Absent in 25g ISO 11290-1:2017
Presumptive Bacillus cereus ≤ 50 CFU/g ISO 7932:2004
Residual Endotoxins ≤ 10 EU/mg JP 4.01