Product name | Esomeprazole Magnesium Trihydrate |
Synonyms | Bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzylimidazole-1-yl) magnesium trihydrate |
CAS No. | 217087-09-7 |
Molecular Formula | 2(C17H18N3O3S).Mg.3(H2O) |
Molecular Weight | 767.17 |
Quality Standard | 98% up, Medicine Grade |
Appearance | White powder |
COA of Esomeprazole Magnesium Trihydrate |
Test items | Specifications | Result |
Appearance | White or slightly coloured powder,slight hygroscopic | almost white powder |
Identification A. IR B.Enantiomeric purity C.Reaction of maganesium D. Water | IR Conforms to the CRS.(2.2.24) Impurity F ≤0.2%(2.2.29) It gives reaction of magnesium(2.3.1) 6.2%~8.0%(2.5.12) | Complies 0.05% Complies 7.3% |
Absorbance | The absorbance is not greater than 0.20 at 440nm.(2.2.25) | 0.12 |
Related substances(HPLC) Impurity E Impurity D Unspecified impurities Total impurity Impurity F | (2.2.29) ≤0.15% ≤0.15% ≤0.10% ≤0.3% ≤0.2%(2.2.29) | 0.04% 0.10% 0.03% 0.2% 0.05% |
Magnesium | 3.30%~3.55% | 3.46% |
Water by K.F. | 6.2%~8.0%(2.5.12) | 7.3% |
Assay(HPLC) | 98.0%~102.0%(2.2.29) | 99.9% |
Residual solvents: a) Acetone b)Ethyl acetate c)Methylene chloride d)Methanol e)Toluene f)Benzene | Not more than 5000ppm Not more than 5000ppm Not more than 100ppm Not more than 3000ppm Not more than 890ppm Not more than 2ppm | 3ppm Not detected Not detected 77ppm Not detected Not detected |
Function of Esomeprazole Magnesium Trihydrate
Esomeprazole Magnesium Trihydrate is used as drugs for gastroesophageal reflux gastropathy and antacids and anti-ulcer.
1. Gastroesophageal reflux disease (GERD).
2. Treatment of erosive reflux esophagitis.
3. Long-term maintenance treatment for patients with cured esophagitis to prevent recurrence.
4. Symptom control of gastroesophageal reflux disease (GERD) combined with appropriate antibacterial therapy to eradicate Helicobacter pylori.
5. Heals duodenal ulcers associated with Helicobacter pylori infection.
6. Prevent the recurrence of peptic ulcers related to Helicobacter pylori.
