Ciprofloxacin Hcl, Form : Powder

Test	Observations	Specification
Characters	Almost white to light yellow crystalline powder	A white to light yellow crystalline powder.
Solubility	Complies	Slightly soluble in acetic acid, practically insoluble in water, methanol and acetone.
Identification Test
A. By IR B. By TLC	Complies Complies	The infrared absorption spectrum of the sample exhibits maxima only at the same wavelength as that of a similar preparation of Difloxacin hydrochloride working standard. A solution of it responds to the tests for chloride.
Appearance of solution	Complies	The solution is clear and not more intensely colored than reference solution BY7.
Water (By KF)	10.23%	Between 8% to 12% w/w.
Loss on Drying	2.15%	Not more than 3.0%
Residue in ignition	0.07%	Not more than 0.10% w/w
Sulphated Ash	Less than 0.1%	Not more than 0.1% w/w
Heavy Metals	Less than 20 ppm	Not more than 20 ppm
Fluorine	8.71%	Not more than 7.8%
Related Substance (HPLC) 1.Indivisual Unknown Impurity 2.Total Impurities 3.Impurity G	0.14% 0.36% 0.42%	Not more than 0.50% Not more than 1.0% Not more than 0.5%
Assay by HPLC (on Anhydrous Basis)	99.61%	Not less than 98.0% and not more than 102.0% w/w