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Rabeprazole sodium
Product Name: Rabeprazole sodium
Synonym: Pariet; Aciphex; Parie; PARIET; RABEPRAZOL SODIUM; RABEPRAZOLE SODIUM; Rebeprazole sodium; SODIUM RABEPRAZOLE; Rabeprazole SoduiM; Dexrabeprazole SodiuM; Rabeprazole SodiuM USP; RABEPRAZOLE, SODIUM SALT; ;
Rabeprazole sodium CAS No.: 117976-90-6
Rabeprazole sodium EINECS No.: 222-630-7
Rabeprazole sodium Molecular formula: C18H20N3NaO3S
Rabeprazole sodium Molecular weight: 381.4245
Rabeprazole sodium Packing: 25KG/Drum
Rabeprazole sodium Content: 99%
Rabeprazole sodium Appearance: White powder
Rabeprazole sodium Grade: Pharmaceutical grade
Rabeprazole sodium Catagory: Pharmaceutical raw material
Function of Rabeprazole Sodium:
Used in the treatment of active duodenal ulcer, active benign gastric ulcer, diffuse or ulcerative gastric, esophageal reflux disease.
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Test items | JP16 | Imported Drug Registration Standard | |
Characters | White to pale yellowish white powder. | White to pale yellowish white powder. | |
Solubility | It is very soluble in water, and freely soluble in ethanol. | Very soluble in water and methanol, freely soluble in ethanol, practically insoluble in ether. | |
Identification |
UV |
Both spectra exhibit similar intensities of absorption at the same wavelengths |
It exhibits maximum absorption at the wavelength of 292nm. |
IR |
Both spectra exhibit similar intensities of absorption at the same wave numbers |
Both spectra exhibit similar intensities of absorption at the same wave numbers |
|
Sodium Salt Reaction |
A solution of Rabeprazole Sodium (1 in 10) responds to the Qualitative Tests <1.09>for sodium salt. |
It responds to the Qualitative Tests for sodium salt. | |
Chromogenic reaction | The solution turns to orange. | ||
Heavy metals | Not more than 10ppm | Not more than 10ppm | |
Color and clarity of solution | Not darker than Reference Solution H. | ||
Related substances |
Individual impurity <0.1% Total impurities < 1.0% |
Total impurities < 1.5% |
|
Loss on drying | Not more than 1.0% | Not more than 1.0% | |
Residual solvents |
Dichloromethane<600ppm Acetone < 5000ppm Ethyl Acetate < 5000ppm Anhydrous alcohol<5000ppm |
Dichloromethane < 600ppm Acetone < 5000ppm Ethyl Acetate < 5000ppm Anhydrous alcohol < 5000ppm |
|
Assay | 98.0%-101.0% | Not less than 98.0% |
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