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Esomeprazole is a proton-pump inhibitor which reduces stomach acid. It is used in the treatment of dyspepsia, peptic ulcer disease, gastroesophageal reflux disease, and Zollinger-Ellison syndrome.
Specification:
|
Item |
Specification |
|
Specific rotation |
+39.5 to +41.5° |
|
State of solution(transmittance) |
Clear 98.0% min. |
|
Chloride[cl] |
0.020% max. |
|
Ammonium [NH4] |
0.02% max. |
|
Sulfate[SO4] |
0.020% max |
|
Iron[Fe] |
10ppm max. |
|
Heavy metals [Pb] |
10ppm max |
|
Arsenic[As2O3] |
1ppm max |
|
Other amino acids |
Chromatographically not detectable |
|
Loss on drying |
0.20% max. |
|
Residue on ignition[sulfated] |
0.10% max. |
|
Assay |
99.0% min |
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. |
