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Pantoprazole Sodium

Pantoprazole Sodium

Quick Details:


Package and Storage:

Packaging Details: 25 kilos/drum
Delivery Detail: 7 days after order

Specifications:
Pantoprazole is used for short-term treatment of erosion and ulceration of the esophagus caused by gastroesophageal reflux disease. Initial treatment is generally of eight weeks’ duration, after which another eight week course of treatment may be considered if necessary

MP 199-202°C
storage temp.
-20°C Freezer
Usage An antiulcerative. Gastric pump inhibitor
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 Not more than 20 ppm Conform
Additional Tests
Total Aerobic Microbials Not more than 800cfu/g 10cfu/g
Yeast and Molds Not more than 800cfu/g 10cfu/g
Bacterial Endotoxine N.D. N.D.
Particle N.D. N.D.
Assay(by chemical) Between 99.0&101.0% 99.59%
Conclusion Conform  to Enterprise Standard

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