Pharmaceutical Grade Nitrofurazone Disinfectant and Antiseptic Bulk API, Nitrofurazone Drug Approval Number, CDE Filing, Pharmacopoeia Standard

Pharmaceutical Grade Nitrofurazone Disinfectant and Antiseptic Bulk API, Drug Approval Number, CDE Registration, Pharmacopoeia Standard

Pharmaceutical grade nitrofurazone is an important raw material for anti-infective drugs, widely used in pharmaceuticals, medical devices, and topical preparations. Its main function is antibacterial disinfection, particularly effective against wound infections, skin ulcers, and other conditions. According to the requirements of the Chinese Pharmacopoeia 2020 Edition (CP), the quality standards of nitrofurazone are strictly regulated to ensure its safety, efficacy, and stability in medications.

1. Chemical Properties of Nitrofurazone

- Chemical Name: Nitrofurazone.

- Chemical Structure: A nitrofuran compound containing nitro and aldehyde functional groups.

- Appearance and Properties:

- Nitrofurazone is a yellow or orange-yellow crystalline powder.

- It has a slight odor and certain chemical stability.

- Solubility: Slightly soluble in water, easily soluble in dimethyl sulfoxide (DMSO) and ethanol.

Pharmaceutical Grade Nitrofurazone Disinfectant and Antiseptic Bulk API, Drug Approval Number, CDE Registration, Pharmacopoeia Standard

- Main Functions of Pharmaceutical Grade Nitrofurazone:

- As an antibacterial agent, it is primarily used for the prevention and treatment of topical wound infections.

- It exhibits bacteriostatic effects against various Gram-positive and Gram-negative bacteria.

Quality Standards of Pharmaceutical Grade Nitrofurazone (CP Edition)

According to the Chinese Pharmacopoeia 2020 Edition, nitrofurazone must meet the following quality control requirements:

- Appearance: Yellow or orange-yellow crystalline powder, free from visible impurities upon visual inspection.

- Identification: Confirmation of characteristic functional groups and chemical structure via ultraviolet absorption spectroscopy or infrared spectroscopy.

- Assay: Nitrofurazone content must not be less than 98.0%.

- Clarity and Color of Solution: Prepared aqueous solution should show no significant turbidity or abnormal color.

- Melting Point Range: Should be between 240°C and 244°C.

- Heavy Metal Limit: Must not exceed 20 ppm to ensure drug safety.

- Impurity Testing: Related impurities must be controlled via thin-layer chromatography or high-performance liquid chromatography (HPLC) to ensure purity.

- Loss on Drying: Total moisture and volatile substances must not exceed 0.5%.

- Acidity or Alkalinity: The pH of the prepared solution must fall within the pharmacopoeia-specified range (typically 5.5-7.5).

Medicinal Functions and Applications of Nitrofurazone

As a pharmaceutical raw material, the main uses of nitrofurazone include the following aspects:

- Topical Antibacterial Agent:

- Formulated into creams, ointments, or gauzes for local disinfection of wounds, burns, ulcers, and infectious skin diseases.

- Applied in medical dressings to promote wound healing.

- Surgical Infection Prevention:

- Used in postoperative wound care to reduce the risk of bacterial infection.

- Veterinary Applications:

- In veterinary medicine, nitrofurazone is also commonly used as a topical anti-infective agent to treat animal wounds and skin ulcers.