Pantoprazole Sodium

Test Item

Standards Required

Test Result

Characters

White to almost white powder.

Almost white powder.

Identification

A:Infrared Absorption

IR Conforms to standard

Complies

B:HPLC

The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.

Complies

C:

It meets the requirements of the pyroantimonate precipitate test for Sodium.

Complies

Water

5.0%-8.0% Method I

6.1%

Heavy Metals

≤0.002% Method II

Complies

Chromatographic purity (HPLC)

 Related compound A

≤0.20%

0.04%

 Related compound B

≤0.15%

Not detected

 Related compound C

≤0.10%

0.04%

 Related compound D+E

≤0.20%

Not detected

 Related compound F

≤0.10%

Not detected

Any other individual impurity

≤0.10%

0.03%

Total impurities

≤0.5%

0.1%

Assay% on dry basis

98.0% - 102.0%

99.7%

Residual solvent

Methanol

≤3000ppm

157ppm

Ethanol

≤5000ppm

142ppm

Methylene chloride

≤100ppm

Not detected

acetoacetate

≤5000ppm

54ppm

Results: The commodity meets the standard of USP35.