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PRODUCT: RANITIDINE HYDROCHLORIDE
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Batch No:0802004
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Manufacture Date:2008-02-12
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Quantity:1000kgs
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Expiration Date:2011-02-11
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ITEMS
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SPECIFICATION
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RESULTS
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Identification
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Positive reaction
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Positive reaction
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PH
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4.5-6.0
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5.2
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Loss on drying
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Not more than 0.75%
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0.10%
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Residue on ignition
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Not more than 0.1%
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Less than 0.5%
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Chromatographic purity
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Ranitidine Related Compound B not more than 0.5%
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Less than 0.5%
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Any other impurity not more than 0.3%
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Less than 0.3%
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The sum of all impurities not more than 1.0%
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Less than 1.0%
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Organic volatile impurities
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Meets the requirements
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Meets the requirements
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Residual solvents
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Meets the requirements
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Meets the requirements
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Assay(dry substance)
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97.5%-102.0%
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99.1%
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