| Product name |
Rebeprazole sodium |
| CAS No. |
117976-90-6 |
Outer Packing |
1kg/bag |
| Production date |
2018.03.20 |
Shelf life |
2019.03.19 |
| Standard adopted |
CP2015 |
| Items of analysis |
Specification |
Results |
| Appearance |
White to yellowish powder |
off White powder |
| Solubility |
This product is easily soluble in water or methanol, and it is easily soluble in ethanol or methylene chloride. It is almost insoluble in ether. |
Conforms |
| Identification |
(1) The solution is orange-red |
Conforms |
| Identification |
2) Maximum absorption at a wavelength of 292 nm |
Conforms |
| Identification |
(3) The infrared absorption spectrum of this product is consistent with that of the reference product of rabeprazole sodium |
Conforms |
| Identification |
(4) Identification of aqueous sodium salt of this product |
Conforms |
| PH |
9.5-11.5 |
10.4 |
| Solution color |
Less than No. 1 yellow standard colorimetric liquid |
Conforms |
| Clarity and color of the solution |
The solution should be clear and colorless, if the color is measured at the wavelength of 440nm, the absorbance must not exceed 0.06 |
0.01 |
| relative substance |
Single impurity ≤ 0.5% |
0.08% |
| relative substance |
Total impurities≤1.0% |
0.33% |
| Dichloromethane |
Dichloromethane must not exceed 600ppm |
＜LOD（LOD=21ppm） |
| Isopropyl ether |
Diisopropyl ether must not exceed 5000 ppm |
46oom |
| Methanol |
Methanol cannot exceed 3000ppm |
＜LOD（LOD=18ppm） |
| Ethanol |
Ethanol must not exceed 5000ppm |
＜LOD（LOD=22ppm） |
| Toluene |
Containing no more than 890 ppm of toluene |
＜LOD（LOD=4ppm） |
| Acetone |
With acetone can not exceed 5000ppm |
93ppm |
| Moisture |
The moisture content must not exceed 5.0% |
1.9% |
| Heavy metal |
With heavy metals can not exceed ten millionths |
＜0.001% |
| Assay |
98.0%-102% |
100.9% |
| Microbial Limit |
The total number of aerobic bacteria should not exceed 1000 CFU/g, the total number of mold and yeast should not exceed 100 CFU/g, and E. coli should not be detected for every 1g |
The total number of aerobic bacteria is less than 10 CFU/g, the total number of molds and yeasts is less than 10 CFU/g, and no E. coli is detected per 1 g |
| Conclusion |
Qualified |
