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Ezetimibe

ANALYSIS

SPECIFICATIONS

RESULTS

ASSAY BY HPLC

(ON ANHYDROUS BASIS

98.0 ~102.0%

99.2%

 

CHEMICAL CONTROL

IDENTIFICATION

IR

Conform with standard IR

 

PHYSICAL CONTROL

DESCRIPTION

white crystalline powder

complies

SOLUBILITY                                   

freely soluble in ethanol, methanol

and acetone, insoluble in water.

complies

SPECIFIC OPITICAL ROTATION

(C-3, methanol at 22)

-24.0~ -33.0 o

-28.1 o

LOSS ON DRYING

1.0%(max)

0.12%

RESIDUE ON IGNITION

0.2%(max)

0.15%

HEAVY METALS

20ppm (max)

complies

TOTAL IMPURITY

1.0%(MAX)

0.52%

SINGLE IMPURITY

0.5%(MAX)

0.32%

 

STORAGE

Cool and dry

SHELF LIFE

2 Years

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