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Clopidogrel Bisulphate I form
Clopidogrel hydrogen sulfate/135046-48-9
Melting point 184oC
Boiling point 447.3oC at 760 mmHg
Flash point 224.3oC

Items of testing  Specifications Results
Characters White to off-white powder White powder
Assay 98.5%~101.5% 99.8%
Solubility  Freely soluble in methanol,
every slightly soluble in acetone,chloroform,water and practically insoluble in aether
Complies
Identification
 
IR: As stipulated
HPLC: As stipulated
It responds to the test for sulfate
Complies
Complies
Complies
Loss on drying ≤0.5% 0.21%
Residue on igtation ≤0.1% 0.03%
Related substances Related compound A≤0.2% 0.07%
  Related compound B≤0.3% 0.07%
  Any other individual impurity≤0.1% 0.05%
  Total impurities≤1.5% 0.24%
Isomer ≤1.0% 0.20%
Residual solvents Dichloromethane ≤300ppm 39.5ppm
  Ethyl acetate≤2000ppm Undetected
  4-Mehyl-2-Pentanone≤4000ppm 1740.7ppm
Conclusion Complies with USP 31