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Introduction
Product Name | Esomeprazole Magnesium |
CAS | 161973-10-0 |
Molecular formula | C34H36MgN6O6S2·3H2O |
Molecular weight | 767.15 |
Grade | Phamaceutical Grade |
Color | White powder |
Purity | 99% |
Shelf life | 2 years |
Function
Specification
Item | Standard | |
Structural data confirmation | 1. H-NMR: The data of structure are identical with reference standard | |
2. HPLC-MS: Ensure the molecular weight of main peak and fragment peak are identical with reference standard | ||
3. IR:The data of IR are identical with that of reference standard | ||
Purity(HPLC) | ≥99.0% | |
Related impurities | Specific single impurity | Meets EP/USP/BP standards |
Non-specific single impurity | ≤0.10% | |
Total Impurities | ≤0.50% | |
Crystal form | Meets EP/USP/BP standards | |
Loss on drying | ≤1.0% | |
Water | ≤1.0% | |
Inorganic salt | ≤0.1% | |
Heavy metals | ≤10 ppm | |
Assay | 99.0%~101.0%(According to EP/USP/BP standards) | |
Microbiological Analysis | ||
Total plate count | ≤1000cfu/g | |
Yeast and Moulds | ≤100cfu/g | |
E. Coli. | Absent | |
Salmonella | Absent | |
S.aureus | Absent |