Neomycin Sulfate Oral Solution
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
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, avors, and preservatives.
Packaging and storage—Preserve in tight, light-resistant containers, preferably at controlled room temperature.
USP Reference standards 〈11〉
USP Neomycin Sulfate RS
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.
Assay—Proceed as directed under Antibiotics—Microbial Assays 〈81〉, using an accurately measured volume of Oral Solution quantitatively diluted with Buffer B.3 to yield a solution having a convenient concentration of neomycin. Quantitatively dilute this stock solution with Buffer B.3 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
