Clemastine Fumarate

Ø      Chemical Name:(+)-(2R)-2-[2-[[[(R)-p-Chloro-a-methyl-a-phenylbenzyl]-oxy]ethyl]-1-methylpyrrolidine fumarate (1:1)

Ø        CAS Registry Number：14976-57-9；15686-51-8(Clemastine)

Ø        Structure：

Ø        Molecular Formula：C₂₁H₂₆CINO·C₄H₄O₄

Ø        Molecular Weight：459.97

Ø        Characters：A white or almost white,crystalline powder , very slightly soluble in water,slightly soluble in methanol.

Ø        Quality standard：conform of  USP28,JP14,EP4.0.

Ø        Packaging and storage：1kg / tin, Preserve in tight, light-resistant containers, at a temperature not exceeding 25 .

Quality standard：

Appearance	white crystalline powder
Identification
TLC	pass
Infrared Absorption	pass
Specific rotation	+15°~+18 °
pH	3.2～4.2
Loss on drying	≤0.5%
Heavy Metal	≤20ppm
Related substances:
Single impurity	≤0.3%
Total impurities	≤1.0%
Assay	98.0%-102.0%