NaturChem Barcelona

Lactulose

LACTULOSE            
TESTS   METHODS/SPECIFICATIONS
Assay Lactulose (HPLC)   50.0 ÷ 52.5 % p/p   ≥ 67.0% p/v
Related substances (HPLC, p/p LTL)   L001 rsm method, equivalent to EP04/2013 and USP Lactulose monograph
Lactose   ≤ 10%
Galactose   ≤ 15%
Fructose   ≤ 1.0%
Epilactose   ≤ 8.0%
Tagatose   ≤ 4.0%
3-deoxy-gliceropentulose   ≤ 4.0%
Impurity G (Unknown)   ≤ 1.5%
Impurity H (Unknown)   ≤ 1.5%
Each Unknown impurities   ≤ 0.5%
Total impurites (excluding Galactose and Lactose)   ≤ 12%
Color  (10g/100ml)    EP 2/≤BY5
Opalescence (10g/100ml)   Clear
pH (10g/100ml)   3.0 ̴ 7.0
Lead   ≤ 0.5 ppm
Aluminium   ≤ 50 ppm
Sulphated Ashes   ≤ 0.2%

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