
Nifuroxazide specification sheet:
Items |
Specifications |
Results |
Appearance |
Bright yellow crystalline powder |
Bright yellow crystalline powder |
Solubility |
Practically insoluble in water,slightly soluble in alcohol and practically insoluble in methylene chloride. |
Complies |
Loss on drying |
0.5%Max |
0.12% |
Heavymetal(Pb) |
0.002 %Max |
Complies |
Sulphated ash |
0.1%Max |
0.09% |
IdentificationBy IR |
The IR spectrum matches thereference standard spectrum |
Complies |
Relatedsubstance |
Impurity A ≤0.05% Impurity B ≤0.3% Impurity C ≤0.3% Impurity D ≤0.3% Impurity E≤0.3% Single unspecified impurities≤0.1% Total impurities other than E ≤0.5% Total ≤0.5% Disregard limit ≤0.05% |
0.05% 0.07% Not Detected Not Detected 0.04% 0.05% Conforms 0.18% Conforms |
UV. Absorption |
The specific absorption atabout 367nm is between 940-1000 |
960 |
RESIDUAL SOLVENTS |
Methanol ≤ 0.3% Alcohol ≤ 0.5% Acetic acid ≤ 0.5% NMP ≤ 0.05% |
Not Detected 0.06% Not Detected NotDetected |
Assay ( on dried ) |
98.5%-101.5% |
99.4% |
Conclusion:The product conforms to EP7.0 standard |
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