Ciprofloxacin hydrochloride / CIPROFLOXACIN HCL
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TERMS
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SPECIFICATION
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Appearance
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Faintly yellowish to light yellow crystals.
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A ,IR
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IR spectrum of sample conforms to that of reference standard.
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B ,HPLC
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The retention time of the major peak of the sample solution corresponds to that of the standard solution,as obtained in the assay.
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C Reaction of chlorides
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A solution of it responds to the tests for chloride
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Assay (on anhydrous basis)
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98.0%-102.0%of C17H18FN3O3.HCL
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Residue on ignition
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Not more than0.1%
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Chloride and sulfate
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Sulfate
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Not more than 0.04%
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Heavy metals
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Not more than 0.002%
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Fluoroquinolonic acid
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(Method 1)
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Not more than0.2%
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Ciprofloxacin ethylenediamine analog (Method 2)
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Not more than0.2%
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Any other individual impurity
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(Method 2)
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Not more than0.2%
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Total impurities(Method 2)
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Not more than0.5%
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PH
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3.0 to 4.5
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