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Nitrofurantoin Macrocrystals is a broad-spectrum antibacterial agent primarily used for the treatment and prevention of urinary tract infections (UTIs) caused by susceptible strains of bacteria such as E. coli, Enterococcus faecalis, and Klebsiella species. The macrocrystalline form provides slower dissolution and improved gastrointestinal tolerance, making it ideal for oral formulations like capsules and tablets.
At Bluepill Express, we manufacture and export pharmaceutical-grade Nitrofurantoin Macrocrystals API compliant with IP, BP, USP, and EP pharmacopeial standards. Our product is synthesized in WHO-GMP and ISO-certified facilities with controlled crystallization processes to ensure uniform crystal size, stability, and purity.
Bluepill Express ensures each batch of Nitrofurantoin Macrocrystals meets stringent quality benchmarks, offering superior bioavailability and excellent batch consistency for global pharmaceutical partners.
Pharmacological Information:
- Therapeutic Class: Urinary Antiseptic / Antibacterial
- Pharmacological Category: Nitrofuran Derivative
- CAS Number: 67-20-9
- Molecular Formula: C8H6N4O5
- Molecular Weight: 238.16 g/mol
- Appearance: Yellow crystalline powder
- Solubility: Slightly soluble in water, soluble in dimethylformamide (DMF)
- Melting Point: 268°C – 272°C (decomposes)
- Storage: Store in a tightly closed container, below 25°C, protected from light and moisture
Mode of Action:
Nitrofurantoin acts by interfering with bacterial enzyme systems, including those involved in carbohydrate metabolism and cell wall synthesis. Upon reduction by bacterial flavoproteins, the drug forms reactive intermediates that damage bacterial DNA, RNA, and other vital cell components, leading to cell death.
The macrocrystalline formulation releases the drug more slowly in the gastrointestinal tract, reducing nausea and improving patient compliance compared to the microcrystalline form.
Applications and Uses:
- Treatment of Urinary Tract Infections (UTIs) caused by susceptible organisms
- Prophylaxis of Recurrent UTIs in women and at-risk patients
- Treatment of Cystitis and Pyelonephritis (mild cases)
- Antibacterial Component in combination therapy for urinary antiseptic formulations
Technical Specifications:
- Assay (Purity): ≥ 99.0%
- Identification: IR spectrum complies with reference standard
- Loss on Drying: ≤ 0.5%
- Residue on Ignition: ≤ 0.1%
- Heavy Metals: ≤ 10 ppm
- Related Substances: ≤ 0.2% (individual impurity)
- Particle Size (Macrocrystals): 100–300 microns
- Microbial Limits: Complies with pharmacopeial standards
Manufacturing & Quality Assurance – Bluepill Express:
- Manufactured under WHO-GMP, ISO 9001:2015, and cGMP conditions
- Controlled crystallization and drying processes for precise particle uniformity
- Low moisture content and stable crystal structure for long shelf life
- Fully analytically tested using HPLC and FTIR methods
- Pharmacopeial compliance: IP / BP / USP / EP
- COA, MSDS, and TDS available for every batch
- Custom packaging and private labeling offered for bulk exports
Packaging & Export Details:
- Available Packs: 1 kg, 5 kg, 10 kg, 25 kg HDPE drums with double-layer LDPE liners
- Shelf Life: 36 months from date of manufacture
- Labeling: As per export and pharmacopeial standards
- Export Markets: Africa, Middle East, Asia, Europe, Latin America
- Documentation Provided:
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Stability Data (on request)
- Non-GMO, BSE/TSE, and Allergen-Free Declarations
