Lactulose Solution
» Lactulose Solution is a solution in water prepared from Lactulose Concentrate. It contains not less than 90.0 percent and not more than 110.0 percent 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.
Microbial enumeration tests 61 and Tests for specified microorganisms 62— The total bacterial count does not exceed 100 cfu per g of lactulose, and the tests for Salmonella species and Escherichia coli are negative.
pH 791: between 2.5 and 6.5, after 15 minutes of contact with the electrodes.
Other requirements— It meets the requirements for the Identification tests, the Related compounds test, and the Assay under Lactulose Concentrate.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Elena Gonikberg, Ph.D.
Senior Scientist
1-301-816-8251		 (MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
61 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339		 (MSA05) Microbiology and Sterility Assurance
62 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339		 (MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 2747
Pharmacopeial Forum: Volume No. 27(1) Page 1796
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.