Nifuroxazide

Appearance

Bright yellow crystalline powder

Solubility

Practically insoluble in water, slightly soluble in alcohol and practically insoluble in methylene chloride

Loss on drying

0.5% Max

Heavy metals(Pb)

0.002% Max

Sulphated ash

0.1% Max

Identification by IR

The IR Spectrum confirms with the reference spectrum

Related substance

Impurity A ≤0.005%Impurity B ≤0.3%Impurity C ≤0.3%Impurity D ≤0.3%Impurity E ≤0.3%Signal unspecified impurities ≤0.1%Total impurities other than E ≤0.5%Total ≤0.5%Disregard limit ≤0.05%

UV.Absorption

The specific absorption at about 367nm is between 940-1000

Residual solvents

Methanol  ≤0.3%Alcohol ≤0.5%
Acetic acid  ≤0.5%NM  ≤0.05%

Assay (On dried)

98.5~101.5%