Name

Omeprazole

Synonyms

5-Methoxy-2-[(4-methoxy-3,5-dimethyl-pyridin-2-yl)methylsulfinyl]-3H-benzoimidazole

Molecular Structure

Molecular Formula

C17H19N3O3S

Molecular Weight

345.42

CAS Registry Number

73590-58-6

ITEMS

STANDARD

RESULTS

Identification

A:

By TLC

positive

B:

IR Conforms to standard

positive

Completeness of solution  

Conforms to standard

positive

Color of solution

The absorbance is not greater than 0.1 at 440nm

0.04

Loss on drying

≤0.5%

0.2%

Residue on ignition

≤0.1%

0.04%

Heavy metals

≤0.002%

<0.002%

Chromatographic purity(HPLC)

Single impurity

≤0.3%

0.12%

Total impurity

≤1.0%

0.28%

Residual solvent

a)Acetone

≤ 5000ppm

554ppm

b)Methylene

≤600ppm 

12ppm

c)Methanol

≤ 3000ppm

50ppm

d)Toluene

≤ 890ppm

28ppm

Assay(HPLC)

98.0%-102.0%

99.9%