Pharmaceutical factory High Quality Esomeprazole Powder CAS 119141 88 7

TESTS

SPECIFICATIONS

RESULTS

Description

White to off-white powder

White powder

IdentifIcation

0.002% SOLUTION IN 0.1 M NaOH exhibits absorption maximum

Conforms

 at 305nm and 276 nm and the ratio is 1.6 to 1.8

The IR spectrum should be concordant with the IR spectrum of

Conforms

 the working standard

Positive reaction

Conforms

Appearance of solution

Solution should be clear

Conforms

PH

10.3~11.3

10.74

Water

≤6.0%

1.16%

Related Substances

Other unknown monohetero ≤0.2%

0.01%

Total impurities≤0.5%

0.06%

HPLC

≥99.5%

99.94%

Specific rotation

-38.0°~-48.0°

-47.54°

Heavy metals

≤20ppm

Conforms

Limit of residual solvents

Dichloromethane≤0.06%

Not detected

Methanol≤0.3%

0.01%

Ethyl acetate≤0.5%

0.01%

Toluene≤0.089%

Not detected

Ethanol≤0.5%

0.27%

Assay

98.0%~102.0%

98.61%

Conclusion: The product complies to Enterprise standard