Paromomycin Oral Solution, chemical structure, molecular formula, Reference Standards

Paromomycin Oral Solution

(Monograph under this new title—to become official June 1,2005)

(Current monograph title is Paromomycin Sulfate Syrup)

»Paromomycin Oral Solution contains an amount of Paromomycin Sulfate equivalent to not less than 90.0percent and not more than 130.0percent 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.

USP Reference standards á11ñ— USP Paromomycin Sulfate RS.

Uniformity of dosage units á905ñ—

FOR ORAL SOLUTION PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.

Deliverable volume á698ñ: meets the requirements.

pHá791ñ: between 7.5and 8.5.

Assay— Proceed with Oral Solution as directed under Antibiotics—Microbial Assays á81ñ,diluting an accurately measured volume of Oral Solution with Buffer No.3to yield a stock solution of convenient concentration.Quantitatively dilute this stock solution with the same buffer to obtain a Test Dilutionhaving a concentration assumed to be equal to the median dose level of the Standard.

(Official June 1,2005)

Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow

Expert Committee:(PA7)Pharmaceutical Analysis 7

USP28–NF23Page 1474

Pharmacopeial Forum:Volume No.28(2)Page 342

Phone Number:1-301-816-8335