ZXFPC0282 Irbesartan

CAS Number: 138402-11-6

Irbesartan

Appearance: White crystalline powder

Quality Index Standard Results

Identification: Rule of ES Conforms
Solubility: Rule of ES Conforms
Related substance
Single: ≤0.5％ 0.2%
Total: ≤1.0％ 0.3%
Loss on drying: ≤0.5％ 0.02%
Heavy metals: ≤20ppm <20ppm
Residue on Ignition: ≤0.1％ 0.08%
Residual Solvents:
Methanol: ≤3000ppm 850ppm
Acetone: ≤3000ppm 1000ppm
Methylenechloride: ≤600ppm Not Detected
n-hexane: ≤300ppm Not Detected
Diisopropyl ether: ≤3000ppm Not Detected
Assay: 98.5-101.5% 99.7%

Conclusion: The Specification conforms to the rule of Enterprise Standard.

 

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