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Items | Specifications | Results |
Appearance | White or almost white powder | Almost white powder |
Identification(IR) | Complies with spectrum of Flubendazole CRS | Complies |
Related substances | Total impurities≤1.5% | 1.3% |
Impurity A≤0.25% | 0.09% | |
Impurity B≤0.25% | 0.09% | |
Impurity C≤0.25% | <0.05% | |
Impurity D≤0.25% | 0.09% | |
Impurity E≤0.25% | 0.15% | |
Impurity F≤0.5% | 0.22% | |
Impurity G≤0.25% | 0.22% | |
Any other impurity with a relative retention between 1.2 and 1.3 ≤0.25% | 0.09%(RRT=1.21) 0.10%(RRT=1.22) 0.06%(RRT=1.27) 0.11%(RRT=1.28) 0.07%(RRT=1.31) | |
Any other impurity≤0.10% | <0.05% | |
Loss on drying | ≤0.5% | 0.1% |
Sulphated ash | ≤0.1% | 0.06% |
Residual solvent | Methanol≤3000ppm Benzene≤2ppm | 467ppm <2ppm |
Assay | 99.0%-101.0%(on dried basis) | 99.5% |
Assay of polymorphic B(IR) | NLT 90.0% | 100.1% |
Conclusion | The test results conform to the current EP standard. | |
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