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Omeprazole 1h-benzimidazole Omeprazole USP/CP grade
Product Description
Product name | Omeprazole |
Cas number | 73590-58-6 |
Molecular formula | C17H19N3O3S |
Molecular weight | 345.42 |
Appearance | White or almost white power |
Assay | 99%-101.0% |
Identification | IR: Same bands as the reference standard |
HPLC | The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay |
Appearance of Solution | Solution S is clear |
Impurities F and G | The solution determined at 440nm is not greater than 0.10 |
Residue of Solvents( In-house) | Methylene chloride≤100ppm |
Methanol≤3000ppm | |
Acetone≤5000ppm | |
Triethylamine≤100ppm | |
Loss on Drying | ≤0.2% |
Sulphated Ash | ≤0.1% |
Heavy Metals | ≤0.002% |
Related Substances (EP) | Impurity D≤0.15% |
Impurity E≤0.15% | |
Unspecified impurities≤0.10% | |
Total impurities≤0.5% | |
Chromatographic purity by HPLC (USP) | Any other individual impurity≤0.10% |
Total impurities≤1.0% | |
Limit of Chloride compound (0671) | ≤12.5ppm |
Molybdenum test by ICP method | ≤10 ppm |
Endotoxin | ≤8.75 EU/mg |
Particle Size | Mean diameter D(4,3)=2-12 µ m |
Upper limit not less than 90%<28µ m | |
Lower limit not more than 15%<1µ m |
Company Information
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