Sinoway Industrial Co.Ltd.
|
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. |
Send Inquiry
|
Hangzhou Sartort Biopharma Co., Ltd
|
Welcome to search www.sartort.com, Sartort would appreciate the opportunity to work with your company by providing the nice quality, service,and technical support with competitive pricing. |
Send Inquiry
|
Hubei YoungXin Pharmaceutical Tech Co.,Ltd.
|
All Pharmaceutical Reference Standards are supplied with Certified COA along with supporting analytical data like HPLC, Mass, NMR, CMR, UV, IR, TGA...Kindly reach me at overseasales11(at)yongstandards.com for more details! |
Send Inquiry
|