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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. |
