U.S. PHARMACOPEIA

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Neomycin Sulfate Oral Solution
» Neomycin Sulfate Oral Solution contains the equivalent of not less than 90.0 percent and not more than 125.0 percent of the labeled amount of neomycin. It may contain one or more suitable colors, flavors, and preservatives.
Packaging and storage— Preserve in tight, light-resistant containers, preferably at controlled room temperature.
Thin-layer chromatographic identification test 201BNP: meets the requirements.
Uniformity of dosage units 905—
FOR ORAL SOLUTION PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.
Deliverable volume 698—
FOR ORAL SOLUTION PACKAGED IN MULTIPLE-UNIT CONTAINERS: meets the requirements.
pH 791: between 5.0 and 7.5.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Proceed as directed under Antibiotics—Microbial Assays 81, using an accurately measured volume of Oral Solution quantitatively diluted with Buffer No. 3 to yield a solution having a convenient concentration of neomycin. Quantitatively dilute this stock solution with Buffer No. 3 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 1493
Pharmacopeial Forum : Volume No. 30(1) Page 133
Phone Number : 1-301-816-8223