| Function: | Visceral System Medication |
|---|---|
| Certification: | GMP |
| Grade Standard: | Medicine Grade |
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| Esomeprazole sodium | ||
| Characters | White to off-white powder | |
| Identify | 0.002% solution IN 0.1 M NaOH exhibits absorption maximum at 305nm and 276 nm and the ratio is 1.6 to 1.8 | |
| The IR spectrum should be concordant with the IR spectrum of the working standard | ||
| Positive reaction | ||
| Appearance of solution | Solution should be clear | |
| PH | 10.3~11.3 | |
| Water | ≤6.0% | |
| Related Substances | Other unknown monohetero ≤0.2% | |
| Total impurities≤0.5% | ||
| HPLC | ≥99.5% | |
| Heavy metals | ≤20ppm | |
| Assay | 98.0%~102.0% | |
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