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Active Pharmaceutical Ingredient
Idebenone

 

Product Name: Idebenone
CAS NO.: 58186-27-9
Description:

Description

An orange yellow crystalline powder, odorless.

Solubility

Soluble in chloroform, methanol and

Ethanol, insoluble in water.

Identification

HPLC similar to the reference standard U.V. similar to the reference standard I.R. similar to the reference standard

E1%1cm

458-486

Clarity of solution

Solution 1% in methanol must be clear

Melting point

52.0 to 55.0 Celsius degree

Loss on drying

Not more than 0.5%

Residue on ignition

Not more than 0.1%

Heavy Metals

Not more than 10ppm

Impurities (HPLC)

Not more than 0.8%

Residue solvents (by GC)

Hexan

Toluene

Ethyl acetate

 

Not more than 0.1%

Not more than 0.1%

Not more than 0.1%

Assay (HPLC)

Not less than 98.5%

 
 
 
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