Rebamipide Rebamipide Rebamipide
we have GMP,it conforms to JP16
Appearance |
White crystalline powder |
Rotation |
1 :20DMF shows no rotation |
Identification |
Should conforms |
Melting point |
About 291℃ |
M-chloro isomer |
≤0.15% |
O-chloro isomer |
≤0.15% |
Debenzoyl rebamipide |
≤0.15% |
Other than rebamipide |
≤0.1% |
Total related substance |
≤0.4% |
Chloride |
≤0.028% |
Heavy metals |
≤10ppm |
Loss on drying |
≤3.0% |
Residue on ignition |
≤0.1% |
Residues |
Methanol ≤0.3% Ethanol ≤0.5% Chloroform ≤0.006% |
Assay (on dried basis) |
99.0%~101.0% |
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