USP Monographs: Lactulose Solution

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.

USP Reference standards

— USP Epilactose RS. USP Fructose RS. USP Galactose RS. USP Anhydrous Lactose RS. USP Lactulose RS.

Microbial limits

— The total bacterial count does not exceed 100 cfu per g of lactulose, and the tests for Salmonella species and Escherichia coli are negative.

791

: between 2.5 and 6.5, after 15 minutes of contact with the electrodes.

Residual solvents

467

: meets the requirements.

(Official January 1, 2007)

Other requirements— It meets the requirements for the Identification tests, the Related compounds test, and the Assay under Lactulose Concentrate.

Auxiliary Information— Staff Liaison : Elena Gonikberg, Ph.D., Scientist

Expert Committee : (MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine

USP29–NF24 Page 1225

Pharmacopeial Forum : Volume No. 27(1) Page 1796

Phone Number : 1-301-816-8251


Search USP29