U.S. PHARMACOPEIA

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Paromomycin Oral Solution
Former title:Paromomycin Sulfate Syrup
» Paromomycin Oral Solution contains an amount of Paromomycin Sulfate equivalent to not less than 90.0 percent and not more than 130.0 percent of the labeled amount of paromomycin (C23H45N5O14). It may contain one or more suitable buffers, colors, flavors, preservatives, and solvents.
Packaging and storage— Preserve in tight containers.
Uniformity of dosage units 905—
FOR ORAL SOLUTION PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.
Deliverable volume 698: meets the requirements.
pH 791: between 7.5 and 8.5.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Proceed with Oral Solution as directed under Antibiotics—Microbial Assays 81, diluting an accurately measured volume of Oral Solution with Buffer No. 3 to yield a stock solution of convenient concentration. Quantitatively dilute this stock solution with the same buffer to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 1643
Pharmacopeial Forum : Volume No. 28(2) Page 342
Phone Number : 1-301-816-8223