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 Rebeprazole 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 |
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.
