Description
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Material: Candesartan Cilexetil |
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CAS No.: 145040-37-5 |
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ITEM |
STANDARD |
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Appearance |
White or almost white powder |
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Solubility |
Practically insoluble in water, freely soluble in methylene chloride and slightly soluble in anhydrous ethanol. |
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Identification |
The IR spectrum is consistent with that obtained with the reference standard. |
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Water |
NMT 0.3% |
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Sulphated ash |
NMT 0.1% |
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Related Substances (HPLC) |
Impurity A NMT 0.15% |
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Impurity B NMT 0.30% |
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Impurity F NMT 0.2% |
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Impurity G NMT 0.2% |
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Impurity H NMT 0.15% |
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Unspecified impurities NMT 0.10% |
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Total impurities NMT 0.6% |
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Residual solvents (GC) |
Methanol NMT 3000ppm |
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Acetone NMT 5000ppm |
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n-Heptane NMT 5000ppm |
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Dichloromethane NMT 600ppm |
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Assay (anhydrous substance) |
99.0~101.0% |
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Particle size |
D90 through 30micron |
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Conclusion: |
The above product conforms to EP Standard. |
