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Irbesartan

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  Post Date: Dec 21,2024
  Expiry Date: Jun 19,2025
  Detailed Description: Cas No. :138402-11-6 Specs:USP/EP
Product IRBESARTAN
CAS NO;138402-11-6
Standard;USP
MF;C25H28N6O
MW;428.53


Specification:
Test Items Standard Result
Description White crystalline powder Complies
Solubility Slightly soluble in alcohol and in methylene chloride, practically insoluble in water Complies
Identification:IR/HPLC Similar to standard Complies
Water ≤0.5% 0.29%
Residue on ignition ≤0.1% 0.04%
Azide ≤0.001% Complies
Heavy metal ≤0.002% Complies
Related compounds
Total compounds ≤0.5% 0.31%
Releated compounds A ≤0.2% 0.05%
Any other compound ≤0.1% 0.04%
Assay 98.0%-102.0% (on anhydrous basis) 99.5%
Residual solvents Ethanol≤5000ppm Not detected
Toluene≤890ppm 75ppm
Dichloromethane≤600ppm Not detected
N,N-Dimethylformamide≤880ppm Not detected
t-Butyl methyl ether≤5000ppm Not detected
Conclusion It complies with all the requirements of USP35


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  CAS Registry Number:

138402-11-6
  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;
  Molecular Formula: C25H28N6O
  Molecular Weight: 428.5294
  Molecular Structure: 138402-11-6 Irbesartan

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