Paromomycin Sulfate
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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)
C23H45N5O14 · xH2SO4
d-Streptamine, [O-2-amino-2-deoxy-α-d-glucopyranosyl-(1→4)-O-[O-2,6-diamino-2,6-dideoxy-β-l-idopyranosyl-(1→3)-β-d-ribofuranosyl-(1→5)]-2- deoxy-, sulfate (salt).
O-2,6-Diamino-2,6-dideoxy-β-l-idopyranosyl-(1→3)-O-β-d-ribofuranosyl-(1→5)-O-[2-amino-2-deoxy-α-d-glucopyranosyl-(1→4)]-2-deoxystreptamine sulfate (salt) CAS RN®: 1263-89-4; UNII: 845NU6GJPS.
Base
615.63 CAS RN®: 59-04-1; 7542-37-2; UNII: 61JJC8N5ZK.
Paromomycin Sulfate is the sulfate salt of an antibiotic substance or substances produced by the growth of Streptomyces rimosus var. paromomycinus, or a mixture of two or more such salts. It has a potency equivalent to not less than 675 µg of paromomycin (C23H45N5O14) per mg, calculated on the dried basis.
Packaging and storage—Preserve in tight containers.
USP Reference standards 〈11〉—
USP Paromomycin Sulfate RS
Identification—
A: Prepare a test solution in water containing 10 mg of paromomycin per mL. Apply 25 µL of this solution and 25 µL of a Standard solution of USP Paromomycin Sulfate RS containing 10 mg of paromomycin per mL to a suitable thin-layer chromatographic plate (see Chromatography 〈621〉) coated with a 0.25-mm layer of chromatographic silica gel. Allow the spots to dry, place the plate in a developing chamber, and develop the chromatogram in a solvent system consisting of a mixture of freshly prepared ammonium acetate solution (4 in 100), n-propyl alcohol, and ammonium hydroxide (30:10:6) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the chamber, mark the solvent front, and allow it to air-dry for 10 minutes. Heat the plate at 105° for 1 hour, allow to cool, and spray with a solution of ninhydrin in butanol (1 in 100). Heat the plate at 105° for 5 minutes: paromomycin appears as a red spot, and the RF value of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution.
B: It meets the requirements of the tests for Sulfate 〈191〉.
Specific rotation 〈781S〉: between +50° and +55°.
Test solution: 50 mg per mL, in water.
pH 〈791〉: between 5.0 and 7.5, in a solution (3 in 100).
Loss on drying 〈731〉—Dry about 100 mg in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5 mm of mercury at 60° for 3 hours: it loses not more than 5.0% of its weight.
Residue on ignition 〈281〉: not more than 2.0%, the charred residue being moistened with 2 mL of nitric acid and 5 drops of sulfuric acid. Assay—Proceed with Paromomycin Sulfate as directed under Antibiotics—Microbial Assays 〈81〉.
