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Uses: Nitazoxanide is used to treat diarrhea in children and adults caused by the protozoa Cryptosporidium or Giardia. Protozoa are suspected as the cause when diarrhea lasts more than 7 days. Nitazoxanide is in a class of medications called antiprotozoal agents.
UN No:
Molecular Formula:
Molecular Weight:
307.28 g/mol


Sr. No. Test Limits
1 Description Light Yellow powder
2 Solubility Freely soluble in Dimethylformamide,
slightly soluble in chloroform and
sparingly soluble in acetone.
3 Identification By
a. By FTIR IR spectra of the sample should be
concordant to that of the Nitazoxanide
b. Identification By HPLC In the Test for Assay, the retention time of the
major peak as obtained in chromatogram of
sample should be corresponds to that obtained
in chromatogram of Standard
4 Loss on Drying (%, w/w) Not more than 0.5
5 Residue on Ignition (%, w/w) Not more than 0.1
6 Melting Point (°C) Between 199°C to 205°C
7 Heavy Metals (ppm) Not more than 10
8 Related Substances by HPLC (%)
Impurity A Not more than 1.0
Any individual impurity Not more than 0.5
Total impurities Not more than 1.5
9 Assay by HPLC (%, w/w)
“C12H9N3O5S”, on dried basis)
Not more than 1.5