Imipenem-Cilastatin

Description

Product Overview

Imipenem-Cilastatin is a high-potency broad-spectrum antibiotic combination, designed for industrial-scale pharmaceutical manufacturing and formulation. It combines the carbapenem antibiotic Imipenem with Cilastatin, a renal dehydropeptidase inhibitor, to enhance stability and bioavailability. Strategically, it is critical in producing life-saving injectable therapies, combating multi-drug resistant bacterial infections, and meeting stringent regulatory standards. Its robust efficacy, consistent purity, and scalable supply make it a cornerstone ingredient for pharmaceutical enterprises seeking reliable, high-quality antibiotic solutions. This product ensures operational efficiency and strengthens market positioning for manufacturers in the critical care segment.

Key Specifications & Technical Characteristics

• Chemical Composition: Imipenem Monohydrate & Cilastatin Sodium
• Purity Level: ≥ 98% (HPLC Assay)
• Form & Physical Characteristics: White to off-white crystalline powder, fine particle size suitable for formulation
• Density: 0.4–0.6 g/cm³ (bulk)
• Solubility: Highly soluble in water
• Packaging Options: 25 kg double-layer PE-lined fiber drums, suitable for bulk pharmaceutical handling
• Shelf Life: 24 months under controlled storage conditions (2–8°C, dry, light-protected)

Core Industrial Applications

• Primary Industries: Pharmaceutical manufacturing, Contract Development & Manufacturing Organizations (CDMOs), hospital pharmaceutical production
• Operational Use Cases:
  • Formulation of intravenous antibiotics for critical care
  • Production of combination therapies targeting resistant bacterial infections
  • Integration into sterile injectable dosage forms and lyophilized powders
• Performance Advantages:
  • Enhanced stability during formulation due to Cilastatin inhibition of renal metabolism
  • Consistently high purity and low impurity profile ensures compliance with global pharmacopeial standards
  • Superior bioactivity compared to standalone carbapenems, reducing formulation failure rates

Competitive Advantages

• Quality Consistency: Batch-to-batch uniformity with strict GMP-compliant production
• Supply Reliability: Industrial-scale capacity with guaranteed lead times for global distribution
• Logistics Capability: Optimized bulk packaging for secure and compliant transport
• Price Competitiveness: Economically viable for high-volume industrial buyers
• Sustainability & Environmental Compliance: Manufactured under environmentally responsible protocols
• Technical Support: Comprehensive documentation, certificates of analysis (COA), and regulatory support available

Commercial & Supply Information

• Minimum Order Quantity (MOQ): Bulk 20 MT
• Loading Capacity: Up to 20 MT per 20-ft container
• Availability: Consistent year-round supply for strategic sourcing decisions

This industrial-grade Imipenem-Cilastatin offering positions pharmaceutical manufacturers to efficiently scale critical antibiotic production while ensuring global compliance, quality assurance, and operational reliability.