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Irbesartan is an angiotensin II receptor antagonist used mainly for the treatment of hypertension. 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 |
---|---|
Synonyms | Irbesartan (GMP); 3-butyl-2-[[4-[2-(2h-tetrazol-5-yl)phenyl]phenyl]methyl]-2,4-diazaspiro[4.4]non-3-en-1-one; 2-BUTYL-3-[[2'-(1H-TETRAZOL-5-YL)[1,1'-BIPHENYL]-4-YL]METHYL]-1,3-DIAZASPIRO[4.4]NON-1-EN-4-ONE; BMS-186295; AVAPRO; APROVEL; SR-47436; 2-butyl-3-{[2'-(2H-tetrazol-5-yl)biphenyl-4-yl]methyl}-1,3-diazaspiro[4.4]non-1-en-4-one |
MolecularFormula | C25H28N6O |
MolecularWeight | 428.53 |
CAS NO | 138402-11-6 |
Density | 1.3g/cm 3 |
Melting point | 180-181°C |
Boiling point | 648.6°C at 760 mmHg |
Refractive index | 1.689 |
Flash point | 346°C |
VapourPressur | 1.05E-16mmHg at 25°C |
Water | NMT 0.5% |
Limit of azide | NMT 10ppm |
Heavy metals | NMT 0.002% |
Appearance | White to Off-white, crystalline powder |
Test Item | Analysis Specification | Result |
Description | white to off-white crystalline powder | white crystalline powder |
Identification IRspectrum | Meets the requirements | Meets the requirements |
UVspectrum | Meets the requirements | Meets the requirements |
Specific rotation | +324.~+328. | +327.7. |
Loss on drying(%) | 0.3max | 0.10 |
Residue on ignition(%) | 0.2max | 0.01 |
Heavy Metals(%) | 0.002max | <0.002 |
Limit of Lovastatin related compound A(%) | 0.5max | 0.22 |
Individual impurity (%) | 0.2max | 0.13 |
Total impurities (%) | 1.0max | 0.5 |
Assay(%) | 98.5~101.0 | 99.50 |
Conclusion | Conform to the requirements of USP30 Edition |
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.
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