Description

Nitrofurantoin is a synthetic nitrofuran derivative antibiotic with the CAS registry number 67-20-9. It is a critical active pharmaceutical ingredient (API) valued for its bactericidal action against a wide spectrum of Gram-positive and Gram-negative uropathogens. This compound is essential for the pharmaceutical industry, specifically in the formulation of oral medications for the treatment and prophylaxis of uncomplicated urinary tract infections (UTIs). Its reliable efficacy makes it a cornerstone in antimicrobial therapy.

Application

• Pharmaceutical API: Primary use as the active ingredient in oral antibiotic formulations for treating urinary tract infections.
• Human Medicine: Manufacture of tablets and capsules for acute cystitis and other uncomplicated lower UTIs.
• Veterinary Medicine: Used in certain veterinary pharmaceutical products for bacterial infections in animals.
• Prophylactic Use: Incorporated into medications for the long-term prevention of recurrent urinary tract infections.
• Clinical Research: Serves as a reference standard and raw material in antimicrobial research and development.
• Generic Drug Manufacturing: A key component for producers of generic antibiotic medications.

Basic Information

Product Name	Nitrofurantoin
CAS No.	67-20-9
Molecular Formula	C8H6N4O5
Molecular Weight	238.16 g/mol
Synonyms	1-[[(5-Nitro-2-furanyl)methylene]amino]-2,4-imidazolidinedione; Furadantin; Macrobid; Macrodantin; N-(5-Nitro-2-furfurylidene)-1-aminohydantoin; Nitrofurantoinum; NSC-24567
EINECS	200-646-5

Quality Control

Our Nitrofurantoin is manufactured and tested to meet stringent pharmacopeial standards, including USP and EP monographs. Every batch undergoes comprehensive analytical testing for identity, purity, potency, and specified impurities to ensure it is suitable for pharmaceutical use. A Certificate of Analysis (COA) documenting all test results is provided with each shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, well-ventilated area at controlled room temperature (15-25°C). Due to its light-sensitive and easily oxidized nature, it is recommended to handle under an inert atmosphere for extended storage and to minimize exposure to air and moisture.

Specification

Item	Specification
Appearance	Yellow crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0%
Loss on Drying	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%, Total impurities ≤ 1.5%
Microbial Enumeration	Meets USP/EP criteria

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.