Pharmaceutical Grade Chondroitin Sulfate | Runxin cGMP Certified Source Factory

Manufacturer Profile: Runxin – Pharmaceutical Excellence Since 1998
Runxin represents 28 years of manufacturing leadership in pharmaceutical-grade chondroitin sulfate production, with specialized expertise in active pharmaceutical ingredient (API) development. Our advanced manufacturing facilities maintain comprehensive international certifications including cGMP, ISO9001, ISO22000, ISO13485, HACCP, HALAL, and FSSC22000, with particular emphasis on pharmaceutical quality systems. Serving global pharmaceutical companies and regulatory-approved manufacturers across 70+ countries, we combine state-of-the-art purification technologies with rigorous pharmaceutical quality standards to deliver chondroitin sulfate APIs of exceptional purity, safety, and therapeutic efficacy.

Product Overview: Pharmaceutical Grade Chondroitin Sulfate
Runxin's Pharmaceutical Grade Chondroitin Sulfate is manufactured under strict cGMP conditions specifically for pharmaceutical applications and regulatory-approved medicines. Available in high-purity specifications (95%, 98%, 99% purity), our product undergoes comprehensive pharmaceutical testing including identity verification, potency analysis, and impurity profiling according to international pharmacopeia standards. The manufacturing process incorporates pharmaceutical-grade purification methods including ion-exchange chromatography, ultrafiltration, and crystallization to ensure compliance with USP, EP, and JP monographs.

Key Advantages

• Pharmacopeia Compliance: Meets USP, EP, and JP standards for pharmaceutical applications

• Validated Manufacturing: Fully validated processes under cGMP conditions

• Regulatory Documentation: Complete DMF and CEP support available

• Therapeutic Consistency: Batch-to-batch consistency for reliable clinical outcomes

• Global Regulatory Acceptance: Suitable for international drug registrations

Technical Specifications

• Appearance: White to off-white crystalline powder

• Purity: 95%, 98%, 99% (HPLC)

• Molecular Weight: 15,000-30,000 Da

• Loss on Drying: ≤8%

• Protein Content: ≤3%

• pH (1% solution): 6.2-7.5

• Heavy Metals: ≤5 ppm

• Sulfate Content: 20-24%

• Microbiological Profile:

• Total Plate Count: <100 CFU/g

• Yeast & Mold: <10 CFU/g

• E. coli: Absent in 10g

• Salmonella: Absent in 25g

• Endotoxin Levels: <0.05 EU/mg

• Residual Solvents: Meets ICH Q3C guidelines

• Solubility: ≥96% in water

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

Applications

• Prescription pharmaceuticals for osteoarthritis treatment

• Regulated dietary supplements with therapeutic claims

• Veterinary pharmaceutical formulations

• Clinical nutrition products

• Medical device coatings

• Advanced drug delivery systems

FAQs About Pharmaceutical-Grade Chondroitin Sulfate

1. What specific quality standards differentiate pharmaceutical-grade from other grades?
   Pharmaceutical-grade chondroitin sulfate must comply with strict pharmacopeia monographs (USP/EP/JP), undergo endotoxin testing, maintain complete manufacturing documentation, demonstrate batch-to-batch consistency through validated methods, and meet stringent impurity profile requirements unsuitable for lower-grade categories.

2. How does your cGMP certification ensure pharmaceutical quality compliance?
   Our cGMP certification, supported by ISO9001, ISO22000, ISO13485, HACCP, HALAL, and FSSC22000 standards, ensures comprehensive quality management including facility and equipment validation, personnel training, process controls, documentation practices, and quality assurance systems meeting international pharmaceutical regulatory expectations.

3. What regulatory documentation package do you provide for drug applications?
   We supply complete regulatory support including Drug Master Files (DMF), Certificate of Suitability (CEP), comprehensive stability data, manufacturing process validation reports, impurity profiles, and all required certification documents to support FDA, EMA, and other international regulatory submissions.

4. Can you supply chondroitin sulfate with specific pharmacopeia compliance?
   Yes, we manufacture chondroitin sulfate compliant with USP, European Pharmacopoeia, or Japanese Pharmacopoeia standards, providing appropriate testing, documentation, and certification for each specific pharmacopeia requirement to meet diverse global regulatory needs.

5. What is your capacity for supporting clinical trial material production?
   With 28 years of pharmaceutical manufacturing experience, we maintain dedicated facilities and processes for clinical trial material production, including small-scale GMP batches for early-phase trials and scalable processes for late-phase and commercial supply, all with complete documentation traceability.

Why Choose Runxin as Your Pharmaceutical Partner

• 28 Years of API Manufacturing: Extensive pharmaceutical experience since 1998

• Complete cGMP Compliance: Full adherence to pharmaceutical manufacturing standards

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

• Quality Assurance Leadership: Stringent testing and documentation protocols

• Technical Partnership: Comprehensive support from development to commercialization

Partner with Pharmaceutical API Specialists
Choose Runxin for your pharmaceutical-grade chondroitin sulfate requirements and leverage our 28 years of cGMP manufacturing excellence. Contact us today to request samples, regulatory documentation, or discuss your specific pharmaceutical application needs. Experience the assurance of pharmacopeia-compliant chondroitin sulfate from a trusted API manufacturer with proven regulatory success and uncompromising quality standards.