Omeprazole Sodium
Omeprazole is a proton pump inhibitor used in the treatment of dyspepsia, peptic ulcer disease,gastroesophageal reflux disease, laryngopharyngeal reflux, and Zollinger-Ellison syndrome.
Other name: Sodium 5-methoxy-2-[(4-methoxy-3,5-dimethyl-pyridin-2-yl)methylsulfinyl]benzoimidazole;5-Methoxy-2-(((4-methoxy-3,5-dimethyl-2-pyridinyl)methyl)sulfinyl)-1H-benzimidazole sodium salt
CAS NO.: 95510-70-6
MF: C17H18N3NaO3S
MW: 367.40
Appearance: white crystalline powder
Standard: USP/BP/CP/EP
Items |
Specification |
Results |
Appearance |
white or almost white powder |
almost white powder |
Identification A, TLC |
positive |
complies |
B, IR |
IR meet the standard |
complies |
Completeness of solution |
meet the standard |
complies |
Color of solution |
not greater than 0.1 at 440nm |
0.02 |
Loss on drying |
≤0.5% |
0.10% |
Residue on ignition |
≤0.1% |
0.02% |
Heavy metals |
≤0.002% |
<0.002% |
Chromatographic purity (HPLC) |
Individual impurity ≤0.10% |
0.03% |
|
Total impurity ≤1.0% |
0.05% |
Residual solvent |
a)acetone≤1500ppm |
723ppm |
|
b)methylene chloride≤100pm |
not detected |
|
c)methanol ≤1000ppm |
33ppm |
|
d)toluene ≤300ppm |
<2.9ppm |
|
e)benzene≤1ppm |
not detected |
Assay (C17H19N3O3S, HPLC) |
98-102% |
100.0% |
Esomeprazole Magnesium Trihydrate
Other name: Bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzylimidazole-1-yl) magnesium trihydrate
MW: 767.17
MF: 2(C17H18N3O3S).Mg.3(H2O)
Appearance:white crystalline powder
Boiling point: 600°C at 760 mmHg
Flash point: 316.7°C
Specification:99%min
Standard: EP/BP/USP
Odor: odorless
Specification:
Test Item |
Guaranteed Quantity |
Result |
Appearance |
White or almost white crystalline powder |
Qualified |
IR |
Similar to standard |
Qualified |
HPLC |
Similar to standard |
Qualified |
Heavy Metals |
≤0.001% |
Negative |
Sulphated Ash |
≤0.1% |
0.04% |
Loss on drying |
≤0.5% |
0.31% |
Related substances |
≤0.5% |
0.45% |
Assay |
99.0%-101.0% |
99.0% |
Esomeprazole Sodium
Other name: 5-Methoxy-2-((S)-((4-methoxy-3,5-dimethyl-2-pyridyl)methyl)sulfinyl-1H-benzimidazole sodium salt
CAS NO.: 161796-78-7
MW: 369.41
MF: C17H20N3NaO3S
Appearance:white crystalline powder
Specification:99%min
Standard: EP/BP/USP
Odor: odorless
Pellets
1 |
Esomeprazole magnesium pellets |
8.5% |
2 |
Esomeprazole magnesium pellets |
22.5% |
3 |
Omeprazle pellets |
8.5% |
Service we can provide:
1. Mixed container, we can mix different items in one container.
2. Quality control, before shipment, free sample for test. After shipment, keep sample for 3 years
3. Prompt shipment with professional documents
4. Packing as your request, with photo before shipment
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To get more information, just feel free to contact with us. Thanks.
Mr. Liu
Qingdao Fraken International Trading Co., Ltd
Address: RM1005 post mansion yan'an three road, Qingdao, China
Web: http://fraken.en.made-in-china.com