(par oh'' moe mye' sin sul' fate).
d-Streptamine, [O-2-amino-2-deoxy--d-glucopyranosyl-(1®4)-O-[O-2,6-diamino-2,6-dideoxy--l-idopyranosyl-(1®3)--d-ribofuranosyl-(1®5)]-2-deoxy-, sulfate (salt).
O-2,6-Diamino-2,6-dideoxy--l-idopyranosyl-(1®3)-O--d-ribofuranosyl-(1®5)-O-[2-amino-2-deoxy--d-glucopyranosyl-(1®4)]-2-deoxystreptamine sulfate (salt) [1263-89-4].
Base 615.64 [59-04-1; 7542-37-2].
» 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
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 AntibioticsMicrobial Assays 81.
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USP35NF30 Page 4223