Nitazoxanide API

Product Overview

Nitazoxanide is a wide-ranging antimicrobial active ingredient.

The structure of this is C12H9N3O5S with a molecular weight of 307.28 g/mol.

Appearance is a yellow crystalline powder. It is practically insoluble in water.

Soluble in ethanol and more readily soluble in DMSO, more so.

It is stable for years if kept under proper conditions.

It can degrade when it comes into contact with heat, light, or water.

Nitazoxanide is a thiazolide derivative. It is an inhibitor of the pyruvate: ferredoxin oxidoreductase (PFOR) enzyme system.

This is required for energy by the majority of parasites and microbials.

Interference stops their metabolism and prevents growth.

Nitazoxanide (55981-09-4) is used mainly in parasitic illnesses.

It is prescribed against Giardia lamblia and Cryptosporidium parvum.

These are some of the worldwide causes of diarrhea. It acts against other protozoa as well as anaerobic bacteria.

There exists data to show that Nitazoxanide is an antiviral agent.

It has been proven scientifically to work on rotavirus, coronavirus, flu, and hepatitis viruses.

Its mechanism of action is via interference with the maturation of viral protein and augmentation of the immune process.

Because of such broad-spectrum coverage, Nitazoxanide is a multi-target API

Appearance: Yellow crystalline powder.
CAS number: 55981-09-4
The structure: C12H9N3O5S
Molecular weight: 307.28 g/mol.
Identification: Matches IR spectrum, UV absorption, and HPLC retention time.
Assay: 98.0–102.0% (dried HPLC basis).
Impurities: Each ≤0.5%, total ≤1.0%.
Loss on drying: ≤0.5%.
Residue on ignition: ≤0.1%.
Elemental impurities: ICH Q3D compliant.
Residual solvents: Within ICH Q3C guidelines.
Particle size: Micronised grades are available; D90 ≤250 μm typical.
Microbial quality: Total aerobic count ≤10³ CFU/g; no objectionable organisms.
Stability: 36 months under conditions of storage recommended, supported by real-time and accelerated data.
Validated test methods and impurity reference data are supplied with each shipment.

Nitazoxanide (55981-09-4) is packed in two-liner 25 kg fiber drums.

Packs of 1 to 5 kg are supplied for R&D or pilot use.

The packaging is tamper-proof, sealed, and labeled with product and batch numbers.

The API must be stored between 15–25 °C, in a dry place, in the absence of sunlight.

to prevent exposure in tightly sealed containers in order not to be exposed to air and moisture.

It must be kept away from heat and oxidizers. Shelf life under the above conditions is 36 months.

Handling: Use protective goggles, coats, and gloves when handling.

Handle in a well-ventilated place to avoid any or minor inhalation of dust.

Waste disposal must be through approved environmental procedures.

Quality, compliance, and reliability matter here at Actiza Pharmaceutical Pvt. Ltd.

Our Nitazoxanide (55981-09-4) is produced in cGMP-certified plants under rigorous process control.

Lot release only after rigorous testing.

We provide complete documentation, including COA, MSDS, stability reports, and impurity data.

Customers can also buy Drug Master Files (DMFs) and elemental impurity studies.

We provide micronized material, bespoke impurity specifications, and flexible packaging.

Technical support from our side in method transfer and USP, EP, and JP compliance is offered.