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Telmisartan
| ITEMS | LIMIT |
| Characters | Appearance: White or slightly yellowish, crystalline powder |
| Solubility: Practically insoluble in water, slightly soluble in methanol, sparingly soluble in methylene chloride. It dissolves in 1 M sodium hydroxide. | |
| Identification | Infrared absorption: Complies with the spectrum obtained with the reference standard |
| Loss on drying | NMT 0.5% |
| Sulphated ash | NMT 0.1% |
| Related substances | Impurity A NMT 0.15% |
| Impurity B NMT 0.15% | |
| Impurity C NMT 0.2% | |
| Impurity D NMT 0.2% | |
| Unspecified impurities NMT 0.1% | |
| Total impurities NMT 1.0 | |
| Residual solvents (GC) | Conform to ICH requirements |
| Assay | 99.0~101.0% |
| (titration, calculated on dried substance) |
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