Rebamipide (♦KFDA Approved♦)

JCP2002, KFDA Approved

Appearance:                 A white crystalline powder
Solubility:        Soluble in DMF, slightly soluble in methanol and 95% ethanol, practically insoluble in water
(Decompose)
Identification:         IR spectrum should comply with CRS
                    UV Absorption maximum 228~232, 327~331
                    UV Absorption minimum 290 ~ 296 
Chloride:                        0.028% Max
Loss on drying:                   3.0% Max
Residue on ignition:               0.10% Max 
Heavy metals:                   0.001% Max 
m-Chlor isomer:                  0.5% Max 
Isolated Benzoyl derivates:         0.3% Max 
Related substances:
Individual impurity:             0.1% Max
Total impurity:                 0.5% Max
Content (on dried basis):            99.0% Min