BTP Pharmaceutical Co.,Limited
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Arshine Group Co.,Ltd.
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Norfloxacin HCl
1.CAS:70458-96-7
2.Assay:99%
3.Standard:USP/BP
4.white powder
TEST
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SPECIFICATION
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RESULT
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Description
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White to pale yellow,hydroscpion, photosensitive,
crystalline powder
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Complies
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Identification
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IR
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Complies
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Appreance of solution
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Complies
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Complies
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Related Substances
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Impurity E
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max.0.1%
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0.01%
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Methyl-Norfloxacin
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max.0.15%
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0.08%
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Unspecicifed Impurities
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max.0.1%
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0.04%
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Total Impurities
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max.0.5%
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0.2%
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Loss on drying
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max.1.0%
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0.3%
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Residue on ignition
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max.0.1%
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0.05%
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Heavy metals
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max.15ppm
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10ppm
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Purity
chromatographic
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The sum of all impurities’peaks is not more than 0.5%
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Complies
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Assay
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99.0%-101.0%
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99.8%
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Residual Solvents Ethanol
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max.5000ppm
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Not detected
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SHAOXING HANTAI PHARMACEUTICAL CO.,LTD.
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Norfloxacin USP/EP
25kgs/drum
GMP/DMF Certificates
Validity: 3 years
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