Pharmaceutical Material Esomeprazole CAS 161796-78-7 Magnesium for Antiulcerative
Product Description
Esomeprazole magnesium
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| Product Name | Esomeprazole magnesium |
| Synonyms | Esomeprazole magnesium;Magnesium 5-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]benzimidazol-1-ide;Bis(5-methoxy-2-{(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}benzimidazol-1-ide) magnesium;Chebi:50309;EsoMeprazole MagnesiuM(NexiuM);EsMeprazole Magne-siuM Trihydrate;MagnesiuM,bis[6-Methoxy-2-[(S)-[(4-Methoxy-3,5-diMethyl-2-pyridinyl)Methyl]sulfinyl-kO]-1H-benziMidazolato-kN3]-, (T-4)-;5-Methoxy-2-((S)-((4-Methoxy-3,5-diMethyl-2-pyridyl)Methyl)sulfinyl-1H-benziMidazole MagnesiuM salt |
| CAS | 161973-10-0 |
| MF | 2(C17H18N3O3S)2.Mg |
| MW | 713.12 |
| Usage | Antiulcerative |
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Description of Esomeprazole magnesium
1.Esomeprazole sold under the brand name Nexium among others, 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.
2.It decreases secretion of acid through inhibition of the H+/K+-ATPase in the parietal cells of the stomach. By inhibiting the functioning of this transporter, the drug prevents formation of stomach acid.
3.Esomeprazole is the (S)-(−)-enantiomer of omeprazole. Esomeprazole is currently sold over the counter in the US and the UK.
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COA
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| Items of analysis | Specification | Results |
| description | a white to off white powder | an off white powder |
| solubility | soluble in N,N-Dimethyl formamide | soluble in N,N-Dimethyl formamide |
| A.IR | The infrared absorption spectrum of sample should be concordant with that of esomeprazole magnesium working standard or with the reference spectrum esomeprazole magnesium | the infrared absorption spectrum of sample is concordant with that of esomeprazole magnesium working standard or with the reference spectrum esomeprazole magnesium |
| B.HPLC | in the assay,the principal peak in the chromatogram obtained with the test solution corresponds to the peak in the chromatogram obtained with the reference solution | in the assay,the principal peak in the chromatogram obtained with the test solution corresponds to the peak in the chromatogram obtained with the reference solution. |
| magnesium content(%,w/w)(on anhydrous basis) | 3.0-3.7 | 3.40 |
| specific optical rotation(°) on anhydrous basis at 25ºC(1.0% w/v solution in methanol) | -135 to -155 | -142.39 |
| a.individual impurity | NMT 0.5 | 0.05 |
| Total impurities | Â NMT 1.0 | 0.16 |
| Heavy metals as Pb(ppm) | NMT 20 | less than 20 |
| water by KF(%,w/w) | 6.0-11.0 | 7.28 |
| assay(%,w/w)(on anhydrous basis) | 98.0-102.0 | 99.5 |
| a.methylene chloride | Â NMT 600 | |
| b.methanol | NMT 3000 | |
| c.acetone | NMT 5000 | |
| Â | NMT 5000 | |
| Â | NMT 890 | |
| Conclusion | Qualified | |
Product Description
Esomeprazole magnesium
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| Product Name | Esomeprazole magnesium |
| Synonyms | Esomeprazole magnesium;Magnesium 5-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]benzimidazol-1-ide;Bis(5-methoxy-2-{(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}benzimidazol-1-ide) magnesium;Chebi:50309;EsoMeprazole MagnesiuM(NexiuM);EsMeprazole Magne-siuM Trihydrate;MagnesiuM,bis[6-Methoxy-2-[(S)-[(4-Methoxy-3,5-diMethyl-2-pyridinyl)Methyl]sulfinyl-kO]-1H-benziMidazolato-kN3]-, (T-4)-;5-Methoxy-2-((S)-((4-Methoxy-3,5-diMethyl-2-pyridyl)Methyl)sulfinyl-1H-benziMidazole MagnesiuM salt |
| CAS | 161973-10-0 |
| MF | 2(C17H18N3O3S)2.Mg |
| MW | 713.12 |
| Usage | Antiulcerative |
_____________________________________________________________________________________________
Description of Esomeprazole magnesium
1.Esomeprazole sold under the brand name Nexium among others, 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.
2.It decreases secretion of acid through inhibition of the H+/K+-ATPase in the parietal cells of the stomach. By inhibiting the functioning of this transporter, the drug prevents formation of stomach acid.
3.Esomeprazole is the (S)-(−)-enantiomer of omeprazole. Esomeprazole is currently sold over the counter in the US and the UK.
_____________________________________________________________________________________________
COA
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| Items of analysis | Specification | Results |
| description | a white to off white powder | an off white powder |
| solubility | soluble in N,N-Dimethyl formamide | soluble in N,N-Dimethyl formamide |
| A.IR | The infrared absorption spectrum of sample should be concordant with that of esomeprazole magnesium working standard or with the reference spectrum esomeprazole magnesium | the infrared absorption spectrum of sample is concordant with that of esomeprazole magnesium working standard or with the reference spectrum esomeprazole magnesium |
| B.HPLC | in the assay,the principal peak in the chromatogram obtained with the test solution corresponds to the peak in the chromatogram obtained with the reference solution | in the assay,the principal peak in the chromatogram obtained with the test solution corresponds to the peak in the chromatogram obtained with the reference solution. |
| magnesium content(%,w/w)(on anhydrous basis) | 3.0-3.7 | 3.40 |
| specific optical rotation(°) on anhydrous basis at 25ºC(1.0% w/v solution in methanol) | -135 to -155 | -142.39 |
| a.individual impurity | NMT 0.5 | 0.05 |
| Total impurities | Â NMT 1.0 | 0.16 |
| Heavy metals as Pb(ppm) | NMT 20 | less than 20 |
| water by KF(%,w/w) | 6.0-11.0 | 7.28 |
| assay(%,w/w)(on anhydrous basis) | 98.0-102.0 | 99.5 |
| a.methylene chloride | Â NMT 600 | |
| b.methanol | NMT 3000 | |
| c.acetone | NMT 5000 | |
| Â | NMT 5000 | |
| Â | NMT 890 | |
| Conclusion | Qualified | |
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