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.
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 Chromatography621) 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 R_Fvalue 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 Sulfate191.
Specific rotation781S: between +50 and +55.
Test solution: 50 mg per mL, in water.
pH791: between 5.0 and 7.5, in a solution (3 in 100).
Loss on drying731- 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 ignition281: 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 Assays81.

Paromomycin sulfate salt [1263-89-4]