Aztreonam

Description

1. Product Overview

Aztreonam is a high-purity monobactam antibiotic active pharmaceutical ingredient (API) used in the formulation of injectable and inhalation-based antimicrobial therapies. It is primarily utilized in the pharmaceutical industry for the treatment of Gram-negative bacterial infections, particularly in patients with β-lactam allergies. The key value proposition lies in its targeted antibacterial efficacy, low cross-reactivity, and critical role in modern anti-infective drug manufacturing. Strategically, aztreonam remains an essential API in global healthcare supply chains, addressing rising antimicrobial resistance and ensuring availability of specialized therapeutic options.

2. Key Specifications & Technical Characteristics

• Chemical Composition:
  • Aztreonam (C₁₃H₁₇N₅O₈S₂)
  • Monobactam β-lactam structure
• Purity Level / Grade:
  • Pharmaceutical grade (USP/EP compliant)
  • Typical purity: ≥98%
  • Residual solvents and impurities controlled per pharmacopeial standards
• Physical Characteristics:
  • Form: Crystalline powder
  • Color: White to off-white
  • Odor: Odorless or faint characteristic
  • Particle size: Controlled micronization available upon request
  • Hygroscopic: Moderate
• Packaging Options:
  • Double-lined sterile pharmaceutical-grade bags
  • Fiber drums (10–25 kg)
  • Customized sterile packaging for API handling
• Shelf Life:
  • Typically 24–36 months under controlled temperature and humidity conditions
  • Store in tightly sealed containers, protected from light and moisture

3. Core Industrial Applications

Primary Industries:

• Pharmaceutical manufacturing
• Contract development and manufacturing organizations (CDMOs)
• Biotechnology firms

Operational Use Cases:

• Active ingredient in injectable antibiotic formulations
• Inhalation therapy formulations for respiratory infections
• Development of hospital-grade anti-infective drugs
• Use in combination therapies targeting resistant Gram-negative pathogens

Performance & Cost Advantages:
Aztreonam offers highly targeted antibacterial activity with minimal cross-reactivity to other β-lactam antibiotics, making it a critical option for sensitive patient populations. Its established clinical efficacy and regulatory acceptance reduce development risk and accelerate time-to-market for finished drug products. For manufacturers, it provides a reliable and differentiated API with strong therapeutic positioning in specialized antibiotic segments.

4. Competitive Advantages

• Quality Consistency: Manufactured under GMP-compliant facilities with strict batch validation
• Supply Reliability: Scalable production supported by established pharmaceutical supply chains
• Logistics Capability: Global export with controlled, compliant pharmaceutical handling and cold-chain options if required
• Price Competitiveness: Optimized cost structure through efficient synthesis and bulk production capabilities
• Sustainability Benefits: Process optimization minimizes waste and environmental impact in API manufacturing
• Technical Documentation: Full regulatory support including DMF, COA, MSDS, and stability data

Positioned as a strategic sourcing decision, aztreonam enables pharmaceutical manufacturers to ensure consistent supply of a critical antibiotic API while maintaining regulatory compliance and competitive production economics.

5. Commercial & Supply Information

• Minimum Order Quantity (MOQ): BULK 20MT
• Loading Capacity (MT per container): Approximately 8–12 MT per 20’ container (pharmaceutical-grade packaging and handling constraints apply)