Description
What is Irbesartan?
Irbesartan is an angiotensin II receptor antagonist used mainly for the treatment of hypertension. It was developed by Sanofi Research (now part of Sanofi-Aventis). It is jointly marketed by Sanofi-Aventis and Bristol-Myers Squibb under the trade names Aprovel, Karvea, and Avapro.
Function
As with all angiotensin II receptor antagonists, irbesartan is indicated for the treatment of hypertension. Irbesartan may also delay progression of diabetic nephropathy and is also indicated for the reduction of renal disease progression in patients with type 2 diabetes, hypertension and microalbuminuria (>30 mg/24 hours) or proteinuria (>900 mg/24 hours).
| Product Name | Irbesartan | ||
| Reference | USP | ||
| Test Items | Specifications | Results | |
| Description | White to off-white crystalline powder | White crystalline powder | |
| Identification | A) IR spectrum is accordant with Irbesartan RS. | Conform | |
| B) The retention time of the major peak of the test solution corresponds to that of the standard solution, as obtained in the Assay. | Conform | ||
| Water | ≤0.5% | 0.2% | |
| Residue on ignition | ≤0,1% | <0.1% | |
| Related Substances (HPLC) | USP Impurity A≤0.2% | <LOQ(LOQ:0.03%) | |
| Any other impurity≤O.1% | 0.02% | ||
| Total impurities≤0.5% | 0.02% | ||
| Residual Azide | ≤10ppm | <LOD(LOD:0.2ppm) | |
| Assay (HPLC) | 98 0%~102.0% (Calculated on anhydrous basis) | 99.8% | |
| Conclusion | Complies with USP | ||
