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Nitrofurantoin Monohydrate Structure

Product Type

API

Grade

USP / BP / EP

Chemical Formula

C8H8N4O5·H2O

IUPAC Name

1-(5-nitro-2-furfurylideneamino)hydantoin monohydrate

CAS NO

139-59-3

Molecular Weight

256.17 g/mol

Chemical Class

Nitrofuran Antibacterial Agent

Synonyms

PHYSIOCHEMICAL PROPERTIES

Appearance Yellow crystalline powder
Solubility Slightly soluble in water; soluble in DMSO; sparingly soluble in alcohol; pH-dependent solubility in acidic media
Melting point ~250°C (decomposes)
pH 5.0–7.0 (depending on formulation)

Product Description

Nitrofurantoin Monohydrate is a highly effective antibacterial API targeting urinary tract pathogens. As the hydrated crystalline form of Nitrofurantoin, it offers improved stability, dissolution, and controlled release properties. It is widely prescribed for acute and chronic urinary tract infections (UTIs) due to its strong urinary antibacterial action and low resistance rates.

Nitrofurantoin Monohydrate

How Nitrofurantoin Monohydrate Works

Nitrofurantoin enters bacterial cells via passive diffusion, where bacterial flavoproteins reduce it to reactive intermediates. These intermediates attack DNA, RNA, and cell-wall proteins, leading to bactericidal effects specifically in urinary tissues. This multi-site mechanism minimizes the development of bacterial resistance.

Use(s)

Adverse Effects

Why choose Salius for Nitrofurantoin Monohydrate?

  1. GMP-Compliant Manufacturing Standards
    Produced in WHO GMP and FDA-audited facilities with robust internal quality controls. Each batch undergoes testing in advanced laboratories for purity, potency, and stability.
  2. Cost-Effectiveness
    Salius Pharma offers competitively priced Nitrofurantoin Monohydrate APIs, ensuring affordability for both regulated and semi-regulated markets.
  3. Global Export Experience & Documentation Support
    Comprehensive regulatory documentation support, including DMF, impurity profiles, stability data, and validation reports, for international submissions.
  4. Documents We Provide
  5. Transparency & Trustworthiness
    Recognized as a Government of India Star Export House with a proven record of on-time delivery and consistent API quality.
Attribute Why Salius Pharma Is a Good Choice
Quality Certification WHO GMP, ISO 9001:2015, FDA audited facilities
Affordability & Generic Access Cost-competitive generics for global supply
Export Experience Proven track record of supplying globally

What You Receive in Our Package

When you order from Salius Pharma, you receive more than just a product — you receive a complete, professionally prepared package that meets international regulatory and quality expectations.

Each Shipment Includes:

Product

Expected Delivery Time

We ensure prompt and reliable shipping worldwide. Delivery times vary depending on destination, order volume, and regulatory requirements.

Overall Delivery Time:

7 to 21 business days from dispatch, depending on your location.

FAQs

It is reduced by bacterial enzymes to reactive intermediates that damage DNA, RNA, ribosomal proteins, and metabolic enzymes, resulting in potent bactericidal activity in urinary tract tissues.

Primarily Gram-negative and some Gram-positive pathogens such as E. coli, Klebsiella (selected strains), Enterococcus faecalis, and Staphylococcus saprophyticus.

Yes. The monohydrate form allows slower dissolution and is commonly used in extended-release (Macrobid-type) capsule formulations.

It is urinary-specific. While active against multiple pathogens, its antibacterial activity is localized to the urinary tract due to rapid renal excretion.

Orders are typically dispatched within 7–14 business days, depending on documentation and QC clearance.

Short-term use is standard. For long-term prophylaxis, periodic monitoring of liver and lung function is advised.

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