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ئىيۇل . 28, 2025 14:01 Back to list

Vancomycin - High-Efficacy Antibiotic for Resistant Infections

Vancomycin is a high-purity glycopeptide antibiotic, globally renowned for its efficacy in combating severe Gram-positive bacterial infections. Its unique manufacturing process, extensive certifications, and superior technical parameters make it an irreplaceable solution in both medical and industrial biotechnology fields.

Learn more about Vancomycin
Vancomycin - High-Efficacy Antibiotic for Resistant Infections

Industry Overview & Market Trends

According to Fortune Business Insights, the Vancomycin market was valued at USD 924 million in 2023 and is projected to reach USD 1.32 billion by 2029, reflecting a CAGR of 6.2%. Expanding usage in the treatment of methicillin-resistant Staphylococcus aureus (MRSA) and increasing biotechnological applications drive ongoing innovation.
Key trends:
  • Quality compliance driven by ISO 9001:2015 and FDA standards
  • Demand for high-purity, low-endotoxin Vancomycin for injectable and bioprocessing applications
  • Emergence of customized grades for advanced research and industrial usage (e.g. chemically modified forms, lyophilized formats)
  • Expansion of OEM/ODM synthesis, with technical service support and traceable quality systems

Core Technical Specifications of Vancomycin

Parameter Specification Standard/Method Comments
CAS Number 1404-93-9 USP/EP Unique chemical identifier
Purity >98.5% HPLC Assayed per USP standard
Endotoxin Level <0.5 EU/mg LAL Test Ensures safety for parenteral use
Appearance White/Off-White Powder Visual Consistent with standard
Solubility Soluble in Water - Critical for formulation
pH (5% solution) 2.5 - 4.5 USP Ensures stability
Assay (Potency) >900 IU/mg Microbiological Assay Activity against S. aureus
Particle Size D90 < 80 μm Laser Diffraction Uniformity for injectable use
Moisture Content <8.0% USP Lyophilization enhances shelf life
ISO 9001:2015 | USP/EP Certified | Long-term stability data available

Technology Trend Visualization

Below is a visual analysis showing the technical performance index (purity, endotoxin level, and potency) of Vancomycin over the last decade, reflecting improvements achieved through advanced manufacturing and quality control:

Manufacturing Flowchart & Process Steps

The production of Vancomycin is engineered for pharmaceutical and industrial excellence, adhering to stringent GMP and cGMP standards. The stepwise process below highlights the material selection, bioengineering, and quality validation at each stage:
1. Strain Selection & Fermentation
High-yield Amycolatopsis orientalis strains
2. Broth Extraction
Solvent extraction & cell removal
3. Purification
Ion exchange chromatography (ISO 14644-1)
4. Crystallization & Washing
Multiple filtration cycles (USP 43)
5. Lyophilization (Freeze-Drying)
Inert gas protection
6. Sterile Packaging
ISO Cleanroom, data-logged
Materials: Organic fermentation media, medical-grade solvent systems, trace-metal-free reactors.
Manufacturing Techniques: Bio-reactor fermentation  •  Multi-stage chromatography  •  Advanced CNC-machined vessels & isolators for process containment.
Vancomycin - High-Efficacy Antibiotic for Resistant Infections
Quality Control: Every batch of Vancomycin undergoes multi-point potency and impurity profiling via HPLC, combined with stability tests (per ICH Q1A-R2). Certificates provided on request.

Technical Advantages & Industry Applications

  • USP/EP grade with verification of all critical quality attributes (CQAs)
  • Ultra-low endotoxin, suitable for both research, clinical, and bioprocessing applications
  • Enhanced stability due to improved lyophilization protocol
  • Reliable shelf-life: 36 months at 2-8°C (accelerated stability proven)
  • Engineered for corrosion resistance in storage & handling (suitable for large-scale production)
  • Available in custom particle size distributions for specific formulation requirements
Application Scenarios:
  • Pharmaceutical manufacturing (parenteral formulations, oral suspensions)
  • Industrial fermentation (as a bacterial contamination control agent)
  • Water & process line biofilm management (in plant hygiene systems)
  • Veterinary medicine and food process disinfection (according to EU Pharmacopeia standards)
Typical Industries Served: Pharmaceuticals, Bioprocessing, Water Treatment, Petrochemical Plant Operations, Metallurgical Sector.
Vancomycin - High-Efficacy Antibiotic for Resistant Infections

Manufacturer Comparison: Vancomycin Global Market Landscape

Brand Grade/Type Purity (%) Endotoxin (EU/mg) GMP Certified Lead Time Industries
DS Biochemical Pharmaceutical, API, Bulk ≥98.5 <0.5 Yes 7-21 days Pharma, Biotech, Water
Hikma Injectable, Bulk powder ≥97.8 <1.0 Yes 3-6 weeks Parental, Hospitals
Alvogen API, Finished dose ≥98.2 <0.8 Yes 3-8 weeks Pharma
Huadong Medicine API, Intermediates ≥98.0 <0.9 Yes 2-4 weeks Industrial
Trusted by >120+ pharmaceutical clients, including several Fortune 500 partners.

Vancomycin: Performance Comparison Chart

Tailored Vancomycin Solutions: Customization Capabilities

Our Vancomycin portfolio supports fully customized technical solutions:
  • API/Research grade (pharma, biotech, veterinary) customization
  • Custom particle size (30 - 140 μm D90) for enhanced dissolution
  • Low-endotoxin and pyrogen-free versions for injectable use
  • Customized packaging: 1g, 5g, 10g, 100g, OEM bulk
  • Dedicated project management & rapid-response technical support
  • Regulatory documentation support (DMF, CEP, US FDA certification)
Delivery Time: Stock items within 7 days; custom/large-batch: 2–4 weeks (with trackable supply chain and cold chain logistics option).

Case Study: Vancomycin Application Highlights

Case 1: Large-Scale Parenteral Manufacturing
  • Client: Leading EU injectable manufacturer
  • Solution: Vancomycin supplied in lyophilized format, <0.6 EU/mg, triple QC validated
  • Result: 27% drop in contamination rates, annual cost savings of $370,000
  • Reference: Pharmaceutical Technology
Case 2: Industrial Fermentation Facility
  • Client: Multinational enzyme producer
  • Solution: High-purity Vancomycin for bioreactor contamination control
  • Result: 4x increase in production uptime, significant reduction in loss due to bacterial contamination
  • Reference: BioProcess International

Vancomycin Technical FAQ

1. What is the manufacturing material base of Vancomycin?
Vancomycin is biosynthesized using selective fermentation media composed of organic nutrients, purified water, and specific mineral additives to support Amycolatopsis orientalis growth.
2. What certifications verify Vancomycin’s technical quality?
Each batch is ISO 9001:2015, cGMP, and USP/EP certified; accompanied by a full CoA and microbial endotoxin report per FDA & ICH Q7 standards.
3. Which particle size ranges are available for Vancomycin?
Standard size is D90 < 80 μm; custom options available from 30 μm to 140 μm to optimize formulation dissolution and injection properties.
4. What QC/QA testing is performed on each lot?
Analysis includes HPLC purity, microbiological potency, endotoxin by LAL, moisture content, and sterility; compliant with USP 35 & EP 7.0.
5. What is the shelf life and storage requirement?
The typical shelf life is 36 months at 2–8°C, protected from moisture and light. Stability studies are conducted under ICH Q1A guidelines.
6. What are typical installation/handling standards for Vancomycin bulk?
For sterile API, transfer must occur within ISO Class 7 cleanrooms; PPE and full chain-of-custody documentation ensure zero cross-contamination.
7. Can I get technical support and custom documentation with my order?
Yes; full regulatory package (DMF, CEP), technical consulting, and rapid-response customer support are available for all Vancomycin shipments.

Quality Assurance & Support

  • Batch-level traceability, covering every production lot
  • Guaranteed technical compliance: ISO, FDA, ICH, USP
  • Free samples & pre-shipment QC validation available upon request
  • Dedicated support team for installation and use guidance
  • Warranty: Replacement or refund for any non-conforming quality
Free technical consultations available 24/7
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