Cefuroxime

Description

1. Product Overview

Cefuroxime is a second-generation cephalosporin antibiotic widely utilized in pharmaceutical manufacturing for the treatment of a broad spectrum of bacterial infections. It functions by inhibiting bacterial cell wall synthesis, making it highly effective against both Gram-positive and Gram-negative organisms. As a critical active pharmaceutical ingredient (API), Cefuroxime plays a central role in the production of oral and injectable antibiotic formulations. Its strong clinical efficacy, proven safety profile, and global regulatory acceptance make it a strategically important compound in the anti-infective drug market. For manufacturers, it represents a high-demand, high-value API with consistent global consumption.

2. Key Specifications & Technical Characteristics

• Chemical Composition: Cefuroxime (C₁₆H₁₆N₄O₈S) or Cefuroxime Sodium (injectable grade)
• Purity Level: ≥ 98.0% (Pharmaceutical Grade, compliant with USP/EP/BP standards)
• Form:
  • Crystalline powder (API)
  • Sterile powder (injectable grade)
• Color: White to off-white
• Solubility: Slightly soluble in water (base form); freely soluble (sodium salt)
• Particle Size: Customizable (micronized grades available upon request)
• Moisture Content: ≤ 1.0% (typical specification)
• Packaging Options:
  • 1 kg / 5 kg / 25 kg fiber drums with double polyethylene lining
  • Custom bulk packaging available for large-scale buyers
• Shelf Life: 24–36 months under recommended storage conditions (cool, dry, light-protected environment)

3. Core Industrial Applications

Primary Industries:

• Pharmaceutical manufacturing
• Contract manufacturing organizations (CMOs)
• Generic drug production companies

Operational Use Cases:

• Production of oral dosage forms (tablets, capsules, suspensions)
• Formulation of injectable antibiotics (Cefuroxime Sodium)
• Development of combination antibiotic therapies

Performance Advantages:

• Broad-spectrum antibacterial activity ensures versatility across multiple formulations
• Strong resistance to β-lactamase enzymes enhances clinical reliability
• Well-established regulatory acceptance simplifies product registration and export
• High stability profile supports efficient manufacturing and longer product shelf life

Commercial Impact:
Cefuroxime enables manufacturers to address high-demand therapeutic areas such as respiratory, urinary tract, and skin infections, ensuring consistent market uptake and revenue generation.

4. Competitive Advantages

• Quality Consistency: Produced under strict GMP-compliant processes with batch-to-batch uniformity
• Supply Reliability: Scalable production capacity ensuring uninterrupted global supply
• Logistics Capability: Efficient export handling with compliant documentation and global shipping experience
• Price Competitiveness: Optimized manufacturing processes enabling cost-effective bulk procurement
• Regulatory Compliance: Conforms to major pharmacopeia standards (USP, EP, BP) with full documentation support (COA, MSDS, DMF where applicable)
• Sustainability: Environmentally responsible production practices with controlled waste management
• Technical Support: Dedicated support for formulation, regulatory queries, and product customization

5. Commercial & Supply Information

• Minimum Order Quantity (MOQ): BULK 20 MT
• Loading Capacity:
  • 20 ft container: ~10–12 MT
  • 40 ft container: ~20–25 MT