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Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East
Monthly Production Capacity: 1000kg
Packaging Information: 25kg/drum 1kg/bottle
Delivery Lead Time: 7 days after payment
Sample Provided: yes
Payment Terms: L/L
Product Information
Product name
Rabeprazole Sodium
CAS No.
117976-90-6
Molecular Formula
C18H20N3NaO3S
Molecular Weight
381.4245
Quality Standard
97% up by HPLC, EP8/GMP/DMF
Appearance
White powder
COA of Rabeprazole Sodium
ITEMS
STANDARDS
RESULTS
Appearance
White or slightly yellowish-white hygoscopic powder
Slightly yellowish-white hygoscopic powder
Solubility
Very soluble to freely soluble in water, and freely soluble in anhydrous ethanol, practically insoluble in heptane.
Complies
Identification
Infrared absorption spectrum is identical to that of rebeprazole sodium reference standard.
Complies
It gives reaction (a) of sodium
Complies
pH
9.5-11.5
10.5
Related substances
(HPLC)
Impurity A: NMT 0.8%
0.05%
Unspecified impurities: NMT 0.10%
0.09%
Total impurities: NMT 1.0%
0.28%
Related substances
(GC)
Methylene chloride: NMT 600ppm
<LOD(LOD=62ppm)
Ethanol: NMT5000ppm
<LOD(LOD=62ppm)
Isopropyl ether: NMT5000ppm
10ppm
Acetone: NMT5000ppm
26ppm
Assay
97.0%-102.0%, calculated on the dried basis
100.6%
Microbial limit
Total aerobic microbial count ≤ 1000cfu/g
< 10cfu/g
Total combined yeasts and molds count ≤ 100cfu/g
< 10cfu/g
Escherichia coli: absence in 1g
Complies
Conclusion
Complies with the requirements of EP8.7
Usage
Function of Rabeprazole Sodium
Rabeprazole is a treatment drug for digestive tract diseases. Its main function is to inhibit the secretion of gastric acid. It is a proton pump inhibitor. This drug has an inhibitory effect on basic gastric acid and the secretion of gastric acid caused by stimulation. It can inhibit the secretion of gastric acid and can also resist Helicobacter pylori. In addition, this drug has no antagonistic effect on choline receptors and histamine receptors. Clinically, rabeprazole is mainly suitable for gastrointestinal diseases such as peptic ulcer and reflux esophagitis.
This drug is relatively safe when used, and there are generally no obvious serious adverse reactions. Patients occasionally see milder side effects such as diarrhea, nausea, fatigue, and dry mouth, which usually disappear after stopping the drug.
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