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Irbesartan
| ITEMS | LIMIT |
| Appearance | White to off-white, crystalline powder |
| Identification | Infrared Absorption: The IR spectrum is consistent with that obtained with the reference |
| The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the standard preparation, as obtained in the assay | |
| Water | NMT 0.5% |
| Limit of azide | NMT 10ppm |
| Heavy metals | NMT 0.002% |
| Related compounds | Compound A NMT 0.2% |
| Any other impurity: NMT 0.1% | |
| Total impurities: NMT 0.5% | |
| Residual solvents (GC) | Ethanol NMT 5000ppm |
| Toluene NMT 890ppm | |
| Dichloromethane NMT 600ppm | |
| N,N-Dimethylformamide NMT 880ppm | |
| t-Butyl methyl ether NMT 5000ppm | |
| Assay (on anhydrous basis) | 98.0 ~ 102.0% |
For the treatment of hypertension.
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