Clemastine fumarate

White or off-white crystalline powder;

Clarity and color of solution   Test solution is colorless or not more intensely colored than Color matching fluid  

Melting Point   140~145℃  

Identification   Infrared AbsorptionTLC  

Specific rotation   [α]D20 +15°～+18 °(c = 1 in methanol)  

PH   3.2～4.2  

Loss on drying   ≤0.5%  

Heavy Metal   ≤20ppm  

Individual impurity≤ 0.5%

Total Impurities ≤1.0%  

Residual solvents   500ppm（Ethanol）  

Assay(dried base)   98.0%～102.0%  

Stability data is available.

Second generation H1 receptor antagonists

Antihistamines.