Paromomycin Sulfate Syrup, chemical structure, molecular formula, Reference Standards

Paromomycin Sulfate Syrup

(Current title—not to change until June 1,2005)

Monograph title change—to become official June 1,2005

See Paromomycin Oral Solution

»Paromomycin Sulfate Syrup contains the equivalent of 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 SYRUP PACKAGED IN SINGLE-UNIT CONTAINERS :meets the requirements.

Deliverable volume á698ñ: meets the requirements.

pHá791ñ: between 7.5and 8.5.

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

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