117976-90-6 Sodium Rabeprazole Rabeprazole
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Product name: API powder Rabeprazole Sodium
Molecular formula: C18H20N3NaO3S
Molecular weight: 381.42
Monosodium(RS)-2-({[4-(3-methoxypropoxy)-3-methylpyridin-2-yl]methyl}sulfinyl)-1H-benzoimidazolide
CAS Number:117976-90-6
Test items |
JP16 |
Imported Drug Registration Standard |
|
Characters |
White to pale yellowish white powder. |
White to pale yellowish white powder. |
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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. |
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Identification
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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. |
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Chromogenic reaction |
The solution turns to orange. |
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Heavy metals |
Not more than 10ppm |
Not more than 10ppm |
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Color and clarity of solution |
Not darker than Reference Solution H. |
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Related substances |
Individual impurity <0.1% Total impurities < 1.0% |
Total impurities < 1.5%
|
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Loss on drying |
Not more than 1.0% |
Not more than 1.0% |
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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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