Ciprofloxacin hydrochloride manufacturer CAS NO.86483-48-9

Product Details

name: ciprofloxacin hydrochloride

batch number: 20101012

batch size: 2000kg packing size: 25kg/drum

certificate no.:20101012 manu date: october 12, 2010

date of release: october 14, 2010 expiry date: october 11, 2013

analysis as per usp 32

items of test	standard	result of test
appearance	white or light yellow crystalline powder	conform
identification (a) ir (b) tlc (c) the reaction of chloride	ir spectrum of sample corresponds to that of reference standard. the intensity and rf value of the principal band obtained from the test solution corresponds to that obtained from the standard solution. a solution of iiresponds to the tests of chloride	conform conform conform
related substances hplc	chromatographic purity ≤ 0.2% ciprofloxacin ethylenediamine analog ≤ 0.2% unspecified impurity ≤ 0.50% total impurities ≤ 0.5%	0.15% <0.11% 0.40%
ph	3.0-4.5	3.7
heavy metals	≤20ppm	<20ppm
fluoroquinolonic acid	≤0.2%	conform
sulphated ash	≤0.04%	<0.04%
water	4.7%-6.7%	5.90%
residue of ignition	≤0.1%	0.05%
residual solvent	ethanol ≤ 5000ppm isoamyl alcohol≤ 4000ppm	560ppm not found
assay (hplc)	98.0%-102%	99.8%

conclusion: it meets the standard usp 32

name: ciprofloxacin hydrochloride

batch number: 20101012

batch size: 2000kg packing size: 25kg/drum

certificate no.:20101012 manu date: october 12, 2010

date of release: october 14, 2010 expiry date: october 11, 2013

analysis as per usp 32

items of test	standard	result of test
appearance	white or light yellow crystalline powder	conform
identification (a) ir (b) tlc (c) the reaction of chloride	ir spectrum of sample corresponds to that of reference standard. the intensity and rf value of the principal band obtained from the test solution corresponds to that obtained from the standard solution. a solution of iiresponds to the tests of chloride	conform conform conform
related substances hplc	chromatographic purity ≤ 0.2% ciprofloxacin ethylenediamine analog ≤ 0.2% unspecified impurity ≤ 0.50% total impurities ≤ 0.5%	0.15% <0.11% 0.40%
ph	3.0-4.5	3.7
heavy metals	≤20ppm	<20ppm
fluoroquinolonic acid	≤0.2%	conform
sulphated ash	≤0.04%	<0.04%
water	4.7%-6.7%	5.90%
residue of ignition	≤0.1%	0.05%
residual solvent	ethanol ≤ 5000ppm isoamyl alcohol≤ 4000ppm	560ppm not found
assay (hplc)	98.0%-102%	99.8%