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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

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

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2. Broth Extraction
Solvent extraction & cell removal

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3. Purification
Ion exchange chromatography (ISO 14644-1)

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4. Crystallization & Washing
Multiple filtration cycles (USP 43)

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5. Lyophilization (Freeze-Drying)
Inert gas protection

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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.

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.

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

Authoritative Information & References:
Pharmaceutical Online: Vancomycin Manufacturing Quality Control
PubMed: Industrial Production and Purification of Vancomycin - Process Advances (2022)
ICH Community: Experiences in Vancomycin USP Compliance

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