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Pantoprazole Sodium
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Pantoprazole Sodium

  • Product Name : Pantoprazole Sodium
  • Grade : IP / BP / USP
  • Therapeutic Category : Antacid
  • CAS No : 138786-67-1
  • Other Name : Pantoprazole
  • COA : Available
  • MSDS : Available

Description

Pantoprazole is used for short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD), maintenance of healing of erosive esophagitis, and pathological hypersecretory conditions including Zollinger–Ellison syndrome.

Specification:

Test  Item

Analysis  Specification

Result

Description

A white to off-white powder

A white powder

Identification

A: Test for sodium

B: IR-spectrum

C.UV-spectrum

 

To be positive

Complies with reference spectrum

Not differ by more than3.0%

 

up to standard

Complies with reference 0.21%

pH

9.5-11.0

10.3

Moisture content by KF

6.0%-8.0%

6.9%

Related substances

Toluene

Acetone

Methlene Dichloride

Not more than 0.3%

Not more than 0.005%

Not more than 0.1%

Not more than0.03%

0.15%

Conform

0.08%

Conform

 

Heavy metals

No t more than 20 ppm

Conform

Additional Tests

 

Total Aerobic Microbials

Not more than800cfu/g

10cfu/g

Yeast and Molds

Not more than800cfu/g

10cfu/g

Bacterial Endotoxine

N.D.

N.D.

Particle

N.D.

N.D.

Assay(by chemical)

Between 99.0&101.0%

99.59%

 

Packaging details:

 

Packaging details:

25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum.

Storage:

Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat

Shelf Life:

5 years if sealed and store away from direct sun light.

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