Shandong Ruiying Pharmaceutical Group Co., Ltd.
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Gliclazide Sustained-release Tablets
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Chuming Pharmaceutical Limited
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Shanghai Agrotree Chemical Co., Ltd
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ITEMS
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RESULTS
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Characteristics
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A white powder
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Solubility
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Practically insoluble in water: freely soluble in methylene chloride;
Sparingly soluble in acetone(96%); slightly soluble in alcohol (96%)
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M.P
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164.0-164.5°C
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Identification
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Conform to the spectrum of the CRS Gliclazide
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Heavy metals
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<10ppm
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Impurity B
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0.3ppm
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Related substances
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<0.10%
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<0.10%
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0.13%
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Loss on drying
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0.1%
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Sulphated ash
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0.01%
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Residual solvents
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Below LOQ
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Below LOQ
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Assay (on dried basis)
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99.5%
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Conclusion
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The test results conform with EP/BP/CP
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