盐酸环丙沙星(USP32).docxVIP

Ciprofloxacin HydrochlorideC17H18FN3O3·HCl·H2O?385.823-Quinolinecarboxylic acid, 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-, monohydrochloride, monohydrate.?1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid, monohydrochloride, monohydrate?[86393-32-0].? Ciprofloxacin Hydrochloride contains not less than 98.0 percent and not more than 102.0 percent of C17H18FN3O3·HCl, calculated on the anhydrous basis.Packaging and storage—?Preserve in tight, light-resistant containers. Store at 25, excursions permitted between 15?and 30.USP Reference standards?11—?USP Ciprofloxacin Ethylenediamine Analog RS.?USP Ciprofloxacin Hydrochloride RS.?USP Fluoroquinolonic Acid RS.Identification—A:?Infrared Absorption?197K.B:?Dissolve a quantity of Ciprofloxacin Hydrochloride in water to obtain a test solution containing 10.0 mg per mL. Dissolve a quantity of?USP Ciprofloxacin Hydrochloride RS?in water to obtain a Standard solution containing 10.0 mg per mL. Separately apply, as 1-cm bands, 5 μL each of the test solution and the Standard solution to a suitable thin-layer chromatographic plate (see?Chromatography?621) coated with a 0.25-mm layer of silica gel mixture. Place the plate in an atmosphere of ammonia for about 15 minutes, then transfer the plate to a suitable unsaturated chromatographic chamber, and develop the chromatogram in a solvent system consisting of a mixture of methylene chloride, methanol, ammonium hydroxide, and acetonitrile (4:4:2:1) 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 the plate to air-dry for about 15 minutes. Examine the plate under both short- and long-wavelength UV light: the intensity and?RF?value of the principal band obtained from the test solution corresponds to that obtained from the Standard solution.C:?A solution of it responds to the tests for?Chloride?191.pH?791:?between 3.0 and 4.5, in a sol