Lactulose Solution
»Lactulose Solution is a solution in water prepared from Lactulose Concentrate.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of lactulose (C12H22O11).
Packaging and storage—
Preserve in tight containers,preferably at a temperature between 2
and 30.Avoid subfreezing temperatures.
and 30.Avoid subfreezing temperatures.
USP Reference standards á11ñ—
USP Epilactose RS.USP Fructose RS.USP Galactose RS.USP Anhydrous Lactose RS.USP Lactulose RS.
Microbial limits á61ñ—
The total bacterial count does not exceed 100cfu per g of lactulose,and the tests for Salmonellaspecies and Escherichia coliare negative.
pHá791ñ:
between 2.5and 6.5,after 15minutes of contact with the electrodes.
Other requirements—
It meets the requirements for the Identificationtests,the Related compoundstest,and the Assayunder Lactulose Concentrate.
Auxiliary Information—
Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 1106
Pharmacopeial Forum:Volume No.27(1)Page 1796
Phone Number:1-301-816-8251