6.Certificate of Analysis
|
Name of product |
F-5(Pantoprazole intermediate)
|
|
Chemical name: |
5-Difluoromethoxy-2-mercapto-1H-Benzimidazole |
|
Batch No.: |
20110118 |
MFR.DATE |
2011-01-01 |
|
Retest Date |
2012-01-01 |
|
|
|
Items |
Specitification |
Results |
|
Appearance |
Light yellow to off white powder |
Conforms |
|
Melting point |
247°Cmin. |
250.2°C |
|
Loss on drying |
1.0%max. |
0.18% |
|
Max single impurity |
1.0%max |
0.16% |
|
Assay(by HPLC) |
99.0%min. |
99.30% |
|
Conclusion |
Conform to enterprise standard |
7.Function:
1.anti-ulcer drugs.
2.Gastric proton pump inhibitors.
3.For the treatment of active peptic ulcer and reflux esophagitis Ehrlich Zollinger syndrome. Acid-related diseases including duodenal ulcer, gastric ulcer, reflux esophagitis and Zhuo - Ai syndrome, especially for ulcers with bleeding, vomiting or can not eat, and intractable ulcer and acute pancreatitis.
4.Can also be used to prevent major surgery or serious injury caused by stress ulcer.
