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Specifications
| Appearance: | White to Pale yellow powder |
| Assay (calculated on the dried basis): | 98.0%~102.0% |
| Solubility: | Soluble in N,N-dimethylacetamide, very slightly soluble in alcohol, practically insoluble in water |
| Particle size: | D90: 100 µm max |
| Identification: | The IR absorption spectrum of the sample should be concordant with that of nitazoxanide standard spectrum The retention time of the major peak of the Sample solution corresponds to that in the chromatogram of the standard solution |
| Loss on drying: | 0.5% max |
| Residue on ignition: | 0.1% max |
| Impurity A: | 0.1% max |
| Aspirin: | 0.1% max |
| Salicylic acid: | 0.1% max |
| Impurity B: | 0.5% max |
| Unspecified impurity: | 0.10% max |
| Total impurity: | 1.0% max |
Applications
1. Human Pharmaceuticals
Nitazoxanide is approved for the treatment of several intestinal protozoal infections, including:
Giardiasis (caused by Giardia lamblia)
Cryptosporidiosis (caused by Cryptosporidium parvum)
Helminthic infections (supportive)
Amebiasis and balantidiasis
It is also used off-label for viral infections:
Rotavirus and Norovirus in pediatric gastroenteritis
Hepatitis B and C (as an adjunct therapy)
Investigated for COVID-19, Zika, influenza, and other emerging viral diseases
2. Veterinary Use
Used to treat protozoal infections in livestock and pets.
Applicable against coccidiosis in calves, lambs, and pigs.
Emerging use in aquaculture and poultry to control parasitic outbreaks.
3. Antiviral Research
Recognized for broad-spectrum antiviral properties against both RNA and DNA viruses.
Under active investigation for potential use in treating:
SARS-CoV-2
MERS-CoV
Zika virus
Influenza A and B
Nitazoxanide interferes with viral maturation and replication, particularly by modifying host cell pathways like eIF4E phosphorylation, which affects viral protein synthesis.
4. Antimicrobial Activity
Demonstrates activity against anaerobic bacteria, including:
Clostridium difficile
Helicobacter pylori
Bacteroides spp.
This makes it a candidate for combination therapies targeting resistant microbial strains.
Benefits
✅ Broad-Spectrum Activity
Simultaneously effective against protozoa, helminths, bacteria, and viruses.
✅ Low Resistance Risk
Unique mechanism of action reduces the likelihood of drug resistance compared to traditional antimicrobials.
✅ Well-Tolerated
Excellent safety profile, especially in pediatric and immunocompromised patients.
Minimal side effects-mostly mild gastrointestinal discomfort.
✅ Oral Bioavailability
Available in tablet and suspension forms for easy administration.
✅ Wide Therapeutic Scope
Suitable for both acute and chronic infections.
Investigational use in oncology and immune modulation therapies.
Conclusion
Nitazoxanide (CAS 55981-09-4) is a multipurpose, cost-effective, and well-tolerated anti-infective agent. With activity across parasites, bacteria, and viruses, it represents an important tool in global health, infectious disease management, and emerging antiviral therapies. Its continued exploration in clinical trials makes it a promising candidate for broader therapeutic use in the future.
