Description

Product Name: Injectable Grade Chondroitin Sulfate API Powder (Biofermentation)
Molecular Weight Range: 10 – 60 kDa
Appearance: White to off-white crystalline powder
Functions:
1.Chondroprotection & Joint Health: Promotes cartilage repair and regeneration. A primary agent for osteoarthritis injectables and joint health supplements.
2.Potent Anti-Inflammatory: Specifically targets and inhibits key inflammatory cytokines (IL-1β, TNF-α) and MMP-13 enzyme activity, significantly reducing cartilage degradation.
3.Viscoelastic & Lubricating: Ideal for Ophthalmic Viscosurgical Devices (OVDs) and intra-articular injections to protect tissues and maintain space during procedures.
4.Tissue Regeneration & Wound Healing: Supports the healing process in corneal repair, post-surgical anti-adhesion barriers, and advanced wound care.
5.Cosmeceutical Enhancement: Used in dermal fillers and anti-aging formulations to improve skin elasticity, provide structural support, and synergize with hyaluronic acid for enhanced results.
Molecular Formula: (C14H21NO14S)n
Molecular Weight: Typically ~20,000 Da (Average within the 10-60 kDa range)

Why Choose Our Injectable Grade Chondroitin Sulfate?
1. Uncompromising Quality & Regulatory Compliance:
We understand that your products depend on the integrity of your raw materials. Our chondroitin sulfate is manufactured in a facility certified with cGMP, ISO 13485 (Medical Devices), and ISO 9001. It also holds Halal, REACH, and FSSC 22000 certifications, making it suitable for a global market across pharmaceuticals, functional foods, and supplements.
2. Biofermentation API Advantage:
Sourced from advanced biofermentation, not traditional animal tissue, our product offers superior consistency, reduced risk of animal-borne pathogens, and is ideal for brands targeting vegetarian/vegan markets. This process allows for precise control over molecular weight and sulfation patterns, resulting in a more predictable and potent biological activity.
3. Technical Superiority for Demanding Formulations:
3.1High Purity & Low Endotoxin: HPLC purity of ≥98% and ultra-low endotoxin levels (<0.1 EU/mg) are critical for injectable and ophthalmic applications, ensuring patient safety and product stability.
3.2Proven Bioactivity: Our product is characterized by its high sulfate content (≥30%), which is directly linked to its enhanced ability to inhibit inflammation and stimulate cartilage matrix synthesis.
3.3Excellent Stability: The powder exhibits high stability, capable of withstanding terminal sterilization processes (e.g., 121°C autoclaving) and is compatible with pre-filled syringes.
4. Customization & Expert Support:
We are more than a supplier; we are your technical partner. We offer customization of molecular weight, viscosity, and formulation (solution/lyophilized powder) to perfectly integrate into your specific product development pipeline. Our technical team is ready to provide support for your R&D and regulatory documentation needs.

Packaging & Storage
Packaging: To ensure stability and sterility, our product is available in multiple packaging options:
Primary: 1g and 5g in sterile glass vials (sealed with butyl rubber stoppers and aluminum caps).
Bulk: 50g in sterile, tamper-evident aluminum cans.

Storage: Store in a cool, dry, and dark place. Keep the container tightly sealed at a temperature between 2°C and 8°C (refrigerated). Protect from moisture and light. Under these conditions, the product has a shelf life of 36 months.

Frequently Asked Questions (FAQ)

Injectable Grade Chondroitin Sulfate Powder

1. What is Injectable Grade Chondroitin Sulfate?
Injectable Grade Chondroitin Sulfate is a high-purity, bio-fermentation derived active pharmaceutical ingredient (API) specifically designed for injectable and high-performance biomedical formulations. It provides exceptional purity, safety, and biocompatibility, suitable for pharmaceutical, nutraceutical, and cosmetic applications.

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2. What are the main applications of Injectable Grade Chondroitin Sulfate?
It is widely used in intra-articular injections for osteoarthritis treatment, ophthalmic viscoelastic devices (OVD), wound healing products, and premium cosmeceutical formulations such as dermal fillers and anti-aging serums.

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3. What are the key quality features of your Chondroitin Sulfate?
Our product is produced under strict cGMP and ISO 13485 standards with ultra-low endotoxin and protein levels. It has a controlled molecular weight range of 10–60 kDa and a high sulfate content (≥30%), ensuring superior anti-inflammatory and chondroprotective activity.

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4. What makes your Chondroitin Sulfate suitable for injectable use?
It is manufactured in sterile, GMP-certified facilities with precise control of endotoxin (<0.05 EU/mg) and impurity levels. Each batch undergoes rigorous quality testing to meet the standards for injectable-grade APIs.

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5. Is the product derived from animal or non-animal sources?
Our Injectable Grade Chondroitin Sulfate is bio-fermentation derived and processed to pharmaceutical-grade purity, minimizing immunogenic risks and ensuring excellent safety and consistency.

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6. Can the molecular weight be customized?
Yes. We offer tailored molecular weight ranges and viscosity levels to meet the specific requirements of your medical, pharmaceutical, or cosmetic formulations.

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7. What certifications and standards do you comply with?
Our production follows cGMP, ISO 9001, ISO 13485, and FDA guidelines. The product can also be supplied with Halal, Kosher, and COSMOS certifications upon request.

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8. How should Injectable Grade Chondroitin Sulfate be stored?
Store the product in a cool, dry environment below 25°C, protected from light and moisture. Under proper conditions, the shelf life is 24 months.

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9. What packaging options are available?
We provide sterile, moisture-proof packaging in 1kg or 5kg units. Custom packaging or sterile ready-to-use grades can be supplied upon request for clinical or R&D applications.

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10. Do you offer technical support for formulation or regulatory documentation?
Yes. Our technical and R&D teams provide professional support for formulation development, stability testing, and regulatory documentation (COA, TDS, MSDS, and DMF support) to assist your product registration and development process.