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138786-67-1 Pantoprazole sodium 5-(Difluoromethoxy)-2-(((3,4-dimethoxy-2-pyridinyl)methyl) sulfinyl)-1H-benzimidazole sodium
Product Name |
Pantoprazole sodium |
CAS |
138786-67-1 |
Molecular Formula |
C16H14F2N3NaO4S |
Molecular Weight |
405.35 |
Assay |
99% |
Appearance |
White powder |
Test Item |
Analysis Specification |
Result |
Description |
A white to off-white powder |
A white powder |
Identification |
|
|
A: Test for sodium |
To be positive |
up to standard |
B: IR-spectrum |
Complies with reference spectrum |
Complies with reference 0.21% |
C.UV-spectrum |
Not differ by more than3.0% |
|
|
|
|
pH |
9.5-11.0 |
10.3 |
Moisture content by KF |
6.0%-8.0% |
6.90% |
Related substances |
Not more than 0.3% |
0.15% |
Toluene |
Not more than 0.005% |
Conform |
Acetone |
Not more than 0.1% |
0.08% |
Methlene Dichloride |
Not more than0.03% |
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% |
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