Gracevit Description

White to pale yellowish white, film-coated round and biconvex tablet with
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printed on one side. (See Table 1.)

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One tablet contains Sitafloxacin hydrate 53.3 mg. equivalent to Sitafloxacin 50 mg.
Sitafloxacin occurs as pale yellowish white to yellowish white crystals or crystalline powder. It is sparingly soluble in phosphoric acid test solution (consisting of 50 g phosphoric acid dissolved in 950 mL water), slightly soluble in 0.1 mol/L hydrochloric acid test solution, acetonitrile and methanol, very slightly soluble in ethanol (99.5), and practically insoluble in water. It appears as light yellowish brownish white depending on lighting conditions.
Physicochemistry: Nonproprietary name: Sitafloxacin hydrate.
Chemical name: (-)-7-[(7S)-7-Amino-5-azaspiro[2.4]hept-5-yl]-8-chloro-6-fluoro-1-[(1R,2S)-2-fluorocyclopropyl]-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid.
Molecular formula: C₁₉H₁₈ClF₂N₃O₃.
Molecular weight: 409.81.
Melting point: 217 to 223°C.
Distribution coefficient: 1-octanol/water at 25°C; 0.244.
Excipients/Inactive Ingredients: D-mannitol (JP), corn starch (JP), low substituted hydroxypropylcellulose (JP), hydroxypropylcellulose (JP), magnesium stearate (JP), hypromellose (JP), titanium oxide (JP), talc (JP), macrogol 6000 (JP), polydimethylsiloxane and silicon dioxide mixture (JPE), carnauba wax (JP).
(JP): The Japanese Pharmacopoeia, (JPE): Japanese Pharmaceutical Excipients.