Gracevit Description

One tablet contains Sitafloxacin hydrate 53.3 mg equivalence 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.
Sitafloxacin hydrate is (-)-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: 217-223°C.
Distribution Coefficient: 1-octanol/water at 25°C; 0.244. (See Table 1.)

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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.