Randomized Controlled Trial
Copyright ©The Author(s) 2018.
World J Gastrointest Pharmacol Ther. Aug 7, 2018; 9(3): 22-30
Published online Aug 7, 2018. doi: 10.4292/wjgpt.v9.i3.22
Table 1 Limits for carbohydrate impurities in Lactulose formulations according to monographs in the European Pharmacopoeia
Lactulose crystalsLactulose liquid1
Epilactose≤ 0.5%≤ 10.0%
Galactose≤ 0.5%≤ 15.0%
Lactose≤ 3.0%≤ 10.0%
Fructose≤ 0.5%≤ 1.0%
Tagatose≤ 0.5%≤ 4.0%
3-Deoxy-D-glyceropentulose-≤ 4.0%
Total impurities≤ 3.0%≤ 12.0% (excluding galactose and lactose)