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Intermediates&Fine Chemicals

Nitrofurantoin GMP

Category:

Intermediates&Fine Chemicals

CAS NO:

67-20-9

Standard:

In-house Standards,

Price Range:

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Main Sales Markets:

North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East,Africa

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INNER MONGOLIA YUANHONG FINE CHEMICAL CO., LTD.

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Basic Info

CAS Number

67-20-9

Pharmacopoeia

In-house Standards

Grade

Pharmaceutical Grade

Is Manufacturer

Samples Provided

Product Description

Nitrofurantoin GMP 67-20-9

AI Product Description

*The following content is generated by AI and is for reference only.

Nitrofurantoin, a synthetic nitrofuran derivative antibiotic with the molecular formula C8H6N4O5 and CAS Registry Number 67-20-9, stands as a cornerstone in the management of uncomplicated urinary tract infections (UTIs). Manufactured under strict Good Manufacturing Practice (GMP) guidelines to ensure purity, potency, and safety, this compound is widely utilized in both macrocrystalline and monohydrate forms for oral administration. Its unique mechanism of action involves the reduction of its nitro group by bacterial enzymes within susceptible organisms, generating reactive intermediates that damage bacterial DNA, ribosomal proteins, and other essential cellular components. This multi-targeted approach significantly reduces the likelihood of resistance development compared to many single-mechanism antibiotics. Primarily indicated for the treatment and prophylaxis of acute and recurrent lower urinary tract infections caused by susceptible strains of Escherichia coli, Enterococcus species, Staphylococcus saprophyticus, and certain Klebsiella and Enterobacter species, Nitrofurantoin achieves high concentrations specifically within the urine while maintaining low systemic levels. This pharmacokinetic profile minimizes systemic toxicity but renders it ineffective for treating pyelonephritis or perinephric abscesses where tissue penetration is required. The drug is available in various dosage forms, including capsules, tablets, and oral suspensions, catering to diverse patient needs across pediatric and adult populations. Clinical adherence to GMP standards during production is critical, as impurities can lead to adverse effects such as pulmonary reactions, hepatotoxicity, or hemolytic anemia, particularly in patients with glucose-6-phosphate dehydrogenase deficiency. Consequently, regulatory bodies mandate rigorous quality control testing for identity, assay, dissolution, and sterility before market release. While generally well-tolerated, common side effects include gastrointestinal disturbances like nausea and vomiting. Despite the emergence of newer antimicrobial agents, Nitrofurantoin remains a first-line therapy due to its efficacy, narrow spectrum of activity against uropathogens, and favorable safety profile when used appropriately. Its continued relevance underscores the importance of maintaining high manufacturing standards to preserve therapeutic value and public health outcomes globally.