Nitrofurazone API

Name of Product Nitrofurazone API
CAS No 59‑87‑0
API Name antibacterial
Grade EP/BP/USP/IP
Status Commercial
Form:- API Powder
Inquire About Nitrofurazone API
Inquiry in product detail page

We are a 100% export-oriented company and do not engage in domestic sales within India.

Product Overview

Nitrofurazone is an antibacterial active drug ingredient. It is also known as Nitrofural. It belongs to the nitrofuran group of chemicals. The product is in yellow crystalline powder form having a slight odor. The CAS number is 59-87-0.

It does not easily dissolve in water. It readily dissolves in alcohol and other polar solvents. It is stable if stored under the appropriate conditions. It decomposes when stored under strong light, heat, or moisture.

Nitrofurazone is bactericidal in a special way. The nitro group inside the cell is reduced by bacterial enzymes. The products formed are reactive. They cause damage to DNA and protein. Because of this, the bacteria cannot develop.Nitrofurazone has a broad spectrum of activity, and resistance development is relatively uncommon compared to other antibacterials.

Each lot is produced under Good Manufacturing Practice (cGMP). A certificate of analysis (COA) is also offered. Assay, impurities, residual solvents, and microbial safety are analysed in the compound. Micronised forms are offered if required.

Therapeutic Applications

Nitrofurazone is used as an antibacterial API topically. Nitrofurazone is effective against a broad spectrum of bacteria. They include Staphylococcus aureus, Streptococcus pyogenes, and Escherichia coli.

The API is antiseptic to wounds and skin surfaces. It is effective against many bacteria, including strains that may show reduced sensitivity to other antibacterial agents. Resistance is not widespread because the compound acts at more than one site in the cell.

Cutaneous absorption is low. This means that there is little danger of systemic exposure. Mild sensitivity, however, is developed by some. 

Specification Parameters

Nitrofurazone is furnished to strict specifications. Analytical reports include validated HPLC methods and impurity data. Reference standards are available upon request. Typical values are given below:

  • Appearance: Yellow crystalline powder.

  • Identification: Positive by IR/UV; HPLC retention time agreeing with reference.

  • Assay: 98.0–102.0% (HPLC, dried basis).

  • Impurities: Any impurity ≤0.5%; total ≤1.0%.

  • Loss on drying: ≤0.5%.

  • Residue on ignition: ≤0.1%.

  • Elemental impurities: Complies with ICH Q3D (Pb, As, Cd, Hg below specified limits).

  • Residual solvents: Complies with ICH Q3C.

  • Particle size: Micronised grades available, D90 ≤250 μm.

  • Microbial quality: Total aerobic count ≤10³ CFU/g; free from objectionable organisms.

  • Stability: Shelf life sustained up to 36 months.

Packaging & Storage

The API is packed in 25 kg fibre drums with two inner liners. Pilot work packs ranging from 1 to 5 kg are also available. Each pack is closed and batch number labelled.

Storage at 15–25 °C in a dry, dark place is advised. Do not expose to humidity, heat, or strong alkali. API is stable under such storage for 36 months. Wear gloves, goggles, and protective apparel when handling. Handle under exhaust when dust is formed. Dispose of waste according to national regulations for nitro compounds.

Why Choose Us

Actiza offer APIs with strict quality control. Nitrofurazone is produced in world-class cGMP facilities. Every batch is subject to pharmacopeial levels testing. A COA, MSDS, and stability report are provided.

Regulatory support is also offered. This would comprise DMF documentation, impurity information, and risk reports. Package and particle size can be customised to project specifications.

We have a strong and stable supply chain. Raw materials are sourced through official sources. Safety stocks are held to avoid shortages. Method transfer and USP, EP, or JP compliance technical support is provided.