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Esomeprazole Magnesium Raw API Drug For Digestive System Diseases

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Esomeprazole Magnesium Specification

Product Name: Esomeprazole Magnesium
CAS: 161973-10-0; 217087-09-7
Natural/Synthetic: Synthetic
Level: Pharmaceutical grade
Content: 99%
Appearance: white powder
Packing: 25kg/cardboard drum
Physicochemical properties: white or almost white crystalline powder.
Category: Pharmaceutical Raw Materials
Deferred products: Gastroesophageal reflux gastropathy medication
Application: It is a new type of proton pump inhibitor that can inhibit H+/K+-ATPase activity. It is mainly used in the treatment of digestive diseases such as gastric ulcer, duodenal ulcer and reflux esophagitis caused by excessive gastric acid secretion. .
Usage and dosage: 1. The treatment of erosive reflux esophagitis, 40mg once a day, even for four weeks. 2. For patients who have not cured or persistent symptoms of esophagitis, it is recommended to re-treat for four weeks. Patients who have been cured of esophagitis prevent long-term maintenance treatment of relapse, 20 mg once daily. 3. Symptoms of Gastroesophageal Reflux Disease (GERD) Control 20mg of patients without esophagitis once daily. If the symptoms are not controlled within 4 weeks of treatment, the patient should be examined further. Once the symptoms are resolved, the subsequent symptom control can be treated with immediate therapy, that is, 20 mg orally if needed, once daily.

 

What is Esomeprazole?

Esomeprazole (Nexium) 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.

 

Esomeprazole Magnesium Certificate of Analysis

Product name esomeprazole magnesium
CAS No. 161973-10-0;217087-09-7 Outer Packing 25kg/drum
Production date 2018.1.5 Shelf life 2023.1.4
Standard adopted IP
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
identification
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 25℃(1.0% w/v solution in methanol) -135 to -155 -142.39
related substances by HPLC(%)
a.individual impurity NMT 0.5 0.05
Total impurities 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
residual solvents by GC-HS(ppm)
a.methylene chloride NMT 600 <LOD(22)
b.methanol NMT 3000 <LOD(236)
c.acetone NMT 5000 <LOD(194)
d.ethyl acetate NMT 5000 <LOD(148)
e.toluene NMT 890 <LOD(35)
Conclusion Qualified

 

Esomeprazole Magnesium Mechanism of action

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.

 

Esomeprazole Magnesium Side Effects

Common side effects include headache, diarrhea, nausea, flatulence, decreased appetite, constipation, dry mouth, and abdominal pain. More severe side effects are severe allergic reactions, chest pain, dark urine, fast heartbeat, fever, paresthesia, persistent sore throat, severe stomach pain, unusual bruising or bleeding, unusual tiredness, and yellowing of the eyes or skin.

 

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