Chondroitin Sulfate 90% USP40 by Runxin | 28 Years Multi-Source Manufacturing

Manufacturer Profile: Runxin – Pharmaceutical Excellence Since 1998
Runxin stands as a globally recognized manufacturer with 28 years of specialized expertise in producing premium pharmaceutical-grade chondroitin sulfate and sodium hyaluronate. Our advanced manufacturing facilities maintain comprehensive international certifications including cGMP, ISO9001, ISO22000, ISO13485, HACCP, HALAL, and FSSC22000, with dedicated focus on pharmaceutical-grade manufacturing standards. Serving pharmaceutical companies and healthcare manufacturers across 70+ countries, we combine multi-source raw material expertise with state-of-the-art purification technologies to deliver active pharmaceutical ingredients (APIs) of exceptional purity, safety, and therapeutic efficacy.

Product Overview: Chondroitin Sulfate 90% USP40
Runxin's Chondroitin Sulfate 90% USP40 is manufactured under strict cGMP conditions with full compliance to United States Pharmacopeia 40 standards. Sourced from multiple approved origins including bovine, porcine, and marine sources, our product undergoes comprehensive quality verification including identity testing, purity analysis, and biological activity assessment. The manufacturing process incorporates pharmaceutical-grade purification methods including ion exchange chromatography, nanofiltration, and controlled crystallization to ensure consistent compliance with international pharmacopeia standards.

Key Advantages

• USP40 Compliance: Full conformity with United States Pharmacopeia 40 standards

• Multi-Source Flexibility: Available from bovine, porcine, and marine sources

• Validated Manufacturing: Fully validated processes under cGMP conditions

• Complete Traceability: Comprehensive documentation for every production batch

• Global Regulatory Acceptance: Suitable for international drug registrations

Technical Specifications

• Appearance: White to off-white crystalline powder

• Purity: 90% (USP40)

• Molecular Weight: 14,000-25,000 Da

• Loss on Drying: ≤10%

• Protein Content: ≤6%

• pH (1% solution): 5.5-7.5

• Heavy Metals: ≤20 ppm

• Sulfate Content: 18-24%

• Microbiological Profile:

• Total Plate Count: <1000 CFU/g

• Yeast & Mold: <100 CFU/g

• E. coli: Absent in 10g

• Salmonella: Absent in 25g

• Residual Solvents: Meets ICH guidelines

• Solubility: ≥90% in water

• Certifications: cGMP, ISO9001, ISO22000, ISO13485, HACCP, HALAL, FSSC22000

Applications

• Prescription pharmaceuticals for osteoarthritis management

• Over-the-counter joint health medications

• Dietary supplements with pharmaceutical-grade quality

• Veterinary pharmaceutical formulations

• Clinical nutrition products

• Medical food applications

FAQs About Pharmaceutical-Grade Chondroitin Sulfate

1. What does USP40 compliance mean for chondroitin sulfate quality?
   USP40 compliance ensures the product meets the latest United States Pharmacopeia standards for identity, purity, strength, and quality. This includes specific testing requirements, acceptance criteria, and manufacturing controls that guarantee consistent pharmaceutical-grade quality.

2. How does multi-source manufacturing benefit pharmaceutical customers?
   Our 28 years of multi-source manufacturing experience provides supply chain security, cost stability, and flexibility to meet specific customer preferences or regulatory requirements for different geographical markets and cultural needs.

3. What documentation do you provide for FDA submissions?
   We provide comprehensive documentation including Certificate of Analysis with USP40 testing results, manufacturing process details, stability data, and all required certification documents (cGMP, ISO9001, ISO22000, ISO13485, HACCP, HALAL, FSSC22000) to support regulatory submissions.

4. Can you customize chondroitin sulfate for specific pharmaceutical formulations?
   Yes, with our 28 years of manufacturing experience, we offer customization options including specific particle size distribution, enhanced solubility profiles, and tailored packaging to meet unique pharmaceutical formulation requirements.

5. How do you ensure batch-to-batch consistency in pharmaceutical-grade production?
   Our integrated quality system, certified under cGMP, ISO9001, ISO22000, ISO13485, HACCP, HALAL, and FSSC22000, implements rigorous process validation, in-process controls, and final product testing to ensure consistent quality, purity, and performance across all production batches.

Why Choose Runxin as Your Pharmaceutical Partner

• 28 Years of Pharmaceutical Experience: Extensive expertise in API manufacturing since 1998

• Multi-Source Manufacturing Capability: Flexible sourcing from bovine, porcine, and marine origins

• Comprehensive Pharmaceutical Certifications: Full compliance with cGMP, ISO9001, ISO22000, ISO13485, HACCP, HALAL, and FSSC22000

• Global Regulatory Expertise: Successful track record with international health authorities

• Quality Assurance Leadership: Stringent testing and documentation for pharmaceutical applications

Partner with a Trusted Pharmaceutical Ingredient Leader
Choose Runxin for your USP40 Chondroitin Sulfate requirements and leverage our 28 years of multi-source manufacturing excellence. Contact us today to request samples, obtain certification documents, or discuss your specific pharmaceutical application needs. Let our expertise in pharmaceutical ingredients and regulatory compliance support your success in developing and manufacturing effective pharmaceutical products for global markets.