Chondroitin Sulfate Sodium Powder — Injection Grade (≥98% HPLC, GMP ICH Q7, DMF Type II)
Chondroitin Sulfate Sodium Injection Grade (CAS 9082-07-9, INCI: Sodium Chondroitin Sulfate, (C₁₄H₁₉NNa₂O₁₄S)n, MW 20–50 kDa) — the pharmaceutical-standard chondroitin sulfate for ophthalmic viscoelastic solutions (OVD), intra-articular injections, and tissue engineering scaffolds. Sourced from bovine tracheal cartilage exclusively from BSE-free countries (Australia, New Zealand, Brazil). Purified via proteolytic extraction, anion-exchange chromatography (DEAE-Sepharose), ethanol precipitation, 0.22 μm sterile filtration, and lyophilization. ≥98% HPLC purity. Meets USP <2099> and EP 01/2025:2064 Injection-Grade monographs with endotoxins ≤0.5 EU/mg (LAL test). GMP (ICH Q7), ISO 9001:2015, ISO 13485, FDA Facility Registration, DMF Type II, HALAL, KOSHER. Bulk pharmaceutical manufacturer and wholesale supplier — injection-grade chondroitin sulfate sodium from UPOR Biotech.
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Chondroitin Sulfate Sodium Injection Grade (CAS 9082-07-9, INCI: Sodium Chondroitin Sulfate, USP: Chondroitin-4-Sulfate Sodium, EP: Natrii Chondroitini Sulfas, (C₁₄H₁₉NNa₂O₁₄S)n, MW 20–50 kDa tightly controlled narrow distribution) is a highly purified pharmaceutical-grade sulfated glycosaminoglycan (GAG) biopolymer that stands apart from all other chondroitin grades through its exceptional purity profile and injectable-quality specification. Chondroitin sulfate is a linear polysaccharide composed of repeating disaccharide units of D-glucuronic acid (GlcA) and N-acetyl-D-galactosamine-4-sulfate (GalNAc-4S), with sulfation predominantly at the 4-position (chondroitin-4-sulfate, CSA). In ophthalmic surgery, CS serves as the dispersive viscoelastic component in ophthalmic viscoelastic devices (OVDs) used during cataract phacoemulsification. The dispersive OVD mechanism is critical: the low-molecular-weight, highly charged CS chains coat and adhere to the corneal endothelium through electrostatic interaction, forming a protective viscoelastic barrier that absorbs and dissipates ultrasonic phacoemulsification energy. Without this protection, the 40 kHz ultrasonic tip would cause significant endothelial cell loss, corneal edema, and delayed visual recovery. The clinical gold standard — the DuoVisc® soft-shell technique — combines Viscoat® (3% sodium hyaluronate + 4% chondroitin sulfate, dispersive coating layer) with Provisc® (1% sodium hyaluronate, cohesive space-maintaining layer). CS provides endothelial protection throughout the procedure while the cohesive HA maintains anterior chamber depth for safe instrument manipulation. In orthopedic applications, CS is combined with hyaluronic acid for intra-articular viscosupplementation injections in knee osteoarthritis — CS inhibits cartilage-degrading enzymes (MMPs, aggrecanases) and provides substrate for endogenous proteoglycan synthesis, complementing HA’s viscoelastic and lubricating properties. Beyond ophthalmology and orthopedics, injection-grade CS is used in wound healing hydrogels, tissue engineering scaffolds, and controlled drug delivery systems. The manufacturing process begins with pharmaceutical-grade bovine tracheal cartilage sourced exclusively from BSE-free countries (Australia, New Zealand, Brazil) with full country-of-origin traceability. After proteolytic extraction, the crude CS undergoes anion-exchange chromatography on DEAE-Sepharose — the critical purification step that separates CS from residual proteins, nucleic acids, and endotoxins based on charge density. This is followed by ethanol precipitation to recover purified CS, dissolution in Water for Injection (WFI), 0.22 μm sterile filtration through validated sterilizing-grade filters, and lyophilization to produce the final sterile powder. Endotoxin control is paramount in ophthalmic applications — ocular tissues are exquisitely sensitive to bacterial endotoxins (lipopolysaccharide, LPS). Even low-level endotoxin contamination (>0.5 EU/mg) introduced into the anterior chamber during cataract surgery can trigger Toxic Anterior Segment Syndrome (TASS), a severe sterile inflammatory condition causing corneal endothelial damage, hypopyon, iris atrophy, and permanent visual loss. The injection-grade specification of endotoxins ≤0.5 EU/mg by LAL test (USP <85>) is 100× stricter than food-grade CS (≤50 EU/mg) and is achieved through the DEAE-Sepharose chromatography step that selectively removes the highly charged LPS molecules. This is the defining quality barrier separating injection-grade from all other chondroitin grades.
As a leading pharmaceutical chondroitin sulfate manufacturer and bulk supplier, UPOR Biotech provides injection-grade chondroitin sulfate sodium powder for pharmaceutical companies, medical device manufacturers, ophthalmic solution producers, contract manufacturing organizations (CMOs), and research institutions worldwide. The global pharmaceutical chondroitin sulfate market is driven by the aging population and increasing cataract surgery volumes (over 28 million procedures annually worldwide), the growing adoption of viscosupplementation for knee osteoarthritis, and expanding regenerative medicine applications. UPOR Biotech’s DMF Type II (Drug Master File) provides complete CMC (Chemistry, Manufacturing, and Controls) data supporting ANDA, 505(b)(2), and medical device 510(k) / PMA regulatory filings — pharmaceutical customers reference the DMF via a Letter of Authorization without accessing proprietary manufacturing details. OEM and contract manufacturing services available with flexible MOQ for pharmaceutical development, clinical trial material, and commercial production. Manufactured under full GMP (ICH Q7) with ISO 13485 medical device quality management system for OVD-grade CS. Every shipment includes comprehensive pharmaceutical documentation: COA with full monograph testing, HPLC chromatogram, GPC molecular weight distribution report, disaccharide composition analysis, endotoxin certificate, sterility certificate, and stability data per ICH Q1A.
Injection-Grade vs Food-Grade Chondroitin — Why Pharmaceutical Purity (Endotoxins ≤0.5 EU/mg, Sterility, USP <788>) Is the GMP Barrier: The Ophthalmic and Intra-Articular Injection CS Difference
The distinction between injection-grade and food-grade chondroitin sulfate represents the widest quality gap in the CS market — and it is defined by four critical parameters that make pharmaceutical CS an entirely different product. Endotoxins are the single most important differentiator: injection-grade requires ≤0.5 EU/mg by LAL test, while food-grade CS typically specifies ≤50 EU/mg — a 100× difference with life-changing clinical consequences. Ocular tissues lack systemic endotoxin clearance; exceed the 0.5 EU/mg limit in an OVD and the result is TASS — permanent corneal damage from sterile inflammation. Sterility (USP <71>) is a binary requirement: injection-grade must demonstrate zero microbial growth after 14-day incubation in fluid thioglycollate medium and soybean-casein digest medium — this test simply does not apply to food-grade CS, which is consumed orally and relies on gastric acid for microbial control. Particulate matter (USP <788>) quantifies subvisible particles: ≥10 μm ≤6000 per vial and ≥25 μm ≤600 per vial for injection-grade. Subvisible particles in an intra-articular injection cause synovial inflammation; in an intraocular injection, they cause mechanical endothelial damage and inflammation. Bioburden (≤10 CFU/g pre-sterilization) is a GMP process-control parameter with no equivalent in food-grade production. Beyond these four parameters, the anion-exchange chromatography (DEAE-Sepharose) purification step is the manufacturing barrier: it selectively removes proteins (≤1% for injection-grade vs up to 5% for food-grade), DNA, and endotoxin to injectable levels. Food-grade CS typically uses only proteolytic digestion and ethanol precipitation — insufficient for injection-quality purity. The GMP (ICH Q7) manufacturing environment with validated cleaning, environmental monitoring, and full batch documentation creates the regulatory framework that food-grade facilities operating under food GMPs (21 CFR 111) cannot match. For pharmaceutical formulators developing injectable products, the choice is unequivocal: only injection-grade chondroitin sulfate sodium meeting USP <2099> and EP 01/2025:2064 with endotoxins ≤0.5 EU/mg, manufactured under ICH Q7 GMP with DMF Type II support, is suitable for parenteral administration.
Technical Specifications
| Property | Specification |
|---|---|
| Product Name | Chondroitin Sulfate Sodium Powder — Injection Grade |
| INCI Name | Sodium Chondroitin Sulfate |
| USP / EP Name | Chondroitin-4-Sulfate Sodium (USP <2099>) / Natrii Chondroitini Sulfas (EP 01/2025:2064) |
| CAS Number | 9082-07-9 |
| Molecular Formula | (C₁₄H₁₉NNa₂O₁₄S)n |
| Molecular Weight | 20–50 kDa (tightly controlled narrow distribution via GPC) |
| Synonyms | Chondroitin Sulfate Sodium Injection Grade; Pharmaceutical Chondroitin; CS Pharma; CSA Injectable; Chondroitin-4-Sulfate Sodium (USP); Natrii Chondroitini Sulfas (EP) |
| Source | Bovine tracheal cartilage — pharmaceutical-grade controlled sourcing exclusively from BSE-free countries: Australia, New Zealand, Brazil. Full country-of-origin lot traceability. |
| Appearance | White to off-white lyophilized powder, hygroscopic |
| Assay (HPLC) | ≥98.0% (anhydrous basis, HPLC-UV at 195 nm, disaccharide compositional analysis) |
| Grade / Standards | Injection / Pharmaceutical Grade. Meets USP <2099> and EP 01/2025:2064 Injection-Grade monographs. GMP (ICH Q7). |
| Identification | IR spectrum conforms to USP Chondroitin Sulfate Sodium RS; HPLC disaccharide profile (Δdi-4S ≥65%, Δdi-6S ≤30%, Δdi-0S ≤5%) matches reference after chondroitinase ABC digestion; specific optical rotation +20° to +30° (c=1, H₂O) |
| Endotoxins | ≤0.5 EU/mg (LAL test, USP <85>) — CRITICAL injection-grade parameter. 100× stricter than food-grade (≤50 EU/mg). Validated for ophthalmic and intra-articular injection. |
| Particulate Matter | USP <788> Method 1 (Light Obscuration Particle Count): ≥10 μm ≤6000 per vial; ≥25 μm ≤600 per vial. Tested after reconstitution in WFI at clinical concentration. |
| Sterility | USP <71> Sterility Test: No evidence of microbial growth after 14-day incubation (Fluid Thioglycollate Medium at 30–35°C; Soybean-Casein Digest Medium at 20–25°C) |
| Bioburden (Pre-Sterilization) | ≤10 CFU/g (TAMC + TYMC, USP <61> / EP <2.6.12>). Pathogens (E. coli, Salmonella, S. aureus, P. aeruginosa) — Absent in 10 g (USP <62> / EP <2.6.13>) |
| Protein | ≤1.0% (Lowry assay or Bradford assay, BSA standard) |
| Loss on Drying | ≤10.0% (105°C, 4 hours) |
| pH (1% Aqueous Solution) | 5.5 – 7.5 |
| Heavy Metals — Lead (Pb) | ≤2 ppm (USP <232> / ICH Q3D, Class 1) |
| Heavy Metals — Arsenic (As) | ≤1 ppm (USP <232> / ICH Q3D, Class 1) |
| Heavy Metals — Mercury (Hg) | ≤1 ppm (USP <232> / ICH Q3D, Class 1) |
| Heavy Metals — Cadmium (Cd), Cobalt (Co), Vanadium (V), Nickel (Ni) | Cd ≤1 ppm (USP <232> / ICH Q3D, Class 1); Co, V, Ni each ≤5 ppm (ICH Q3D, Class 2A/2B) |
| Residual Solvents | Ethanol ≤5000 ppm (ICH Q3C Class 3). Methanol, acetone, isopropanol — each ≤3000 ppm. No Class 1 or Class 2 solvents used in manufacturing. |
| Source Country Origin | Australia, New Zealand, Brazil — BSE-free countries per OIE (WOAH) classification. Country of origin verified per lot with full traceability documentation. |
| DMF Status | Type II Drug Master File (DMF) on file with US FDA. Letter of Authorization (LOA) available upon executed Confidentiality Agreement. Supports ANDA and 505(b)(2) filings. |
| Certifications | GMP (ICH Q7), ISO 9001:2015, ISO 13485, FDA Facility Registration, DMF Type II, HALAL, KOSHER, BSE/TSE-Free Certificate (country-of-origin verified) |
| Packaging | 100 g / 500 g / 1 kg pharmaceutical-grade HDPE bottles with tamper-evident seal and desiccant; 5 kg / 10 kg double PE-lined aluminum foil bags in fiber drums |
| Storage | 2–8°C, tightly sealed in original container, protect from light and moisture. Lyophilized powder is hygroscopic. |
| Shelf Life | 3 years from date of manufacture under recommended storage conditions (real-time stability data at 2–8°C) |
Key Benefits — Chondroitin Sulfate Sodium Injection Grade
Injectable-Grade Purity — Endotoxins ≤0.5 EU/mg (100× Stricter Than Food-Grade)
The defining pharmaceutical quality barrier: endotoxins ≤0.5 EU/mg by LAL test versus ≤50 EU/mg for food-grade CS. Achieved through anion-exchange chromatography (DEAE-Sepharose) purification. Validated for ophthalmic injection — protects against TASS. Sterile per USP <71>, particulate-controlled per USP <788>.
≤0.5 EU/mgOphthalmic Viscoelastic-Grade — Corneal Endothelial Protection in Cataract Surgery
Dispersive viscoelastic CS coats and protects the corneal endothelium during phacoemulsification, absorbing ultrasonic energy that would otherwise cause endothelial cell loss. Used in the DuoVisc® soft-shell technique (Viscoat® CS+HA). Supported by decades of clinical evidence in anterior segment surgery.
OVD GradeFull GMP & DMF Regulatory Package — Supports ANDA, 505(b)(2) & 510(k) Filings
GMP (ICH Q7) manufacturing, DMF Type II with complete CMC data, ISO 13485 medical device QMS. Letter of Authorization for DMF cross-reference. Meets USP <2099> and EP 01/2025:2064 monographs. Comprehensive pharmaceutical documentation with every shipment.
DMF + GMPBSE-Free Verified Sourcing — Australia, New Zealand, Brazil Origin
Bovine tracheal cartilage sourced exclusively from BSE-free countries per OIE (WOAH) classification. Full country-of-origin lot traceability from raw material to finished lyophilized product. BSE/TSE-Free Certificate provided with every shipment. HALAL and KOSHER certified.
BSE-Free VerifiedApplications
Ophthalmic Viscoelastic Solutions (OVD) for Cataract Surgery
Dispersive viscoelastic CS component in OVDs (Viscoat®, DuoVisc®) — protects corneal endothelium during phacoemulsification. Soft-shell technique: CS coats endothelium + HA maintains anterior chamber depth. Requires endotoxins ≤0.5 EU/mg and sterility per USP <71>.
Intra-Articular HA + CS Combination Injections for Knee Osteoarthritis
Viscosupplementation combining CS (cartilage protection, MMP inhibition, proteoglycan synthesis substrate) with HA (viscoelasticity, lubrication). Growing market for combination injections over HA-only products. DMF support for 510(k) and ANDA filings.
Wound Healing Hydrogels & Tissue Engineering Scaffolds
Injectable-grade CS as building block for CS-based hydrogels, electrospun scaffolds, and 3D-bioprinted constructs for dermal wound healing, cartilage regeneration, and controlled drug delivery. Sterile, low-endotoxin CS essential for in vivo tissue engineering applications.
Pharmaceutical Reference Standards & Analytical Method Validation
High-purity injection-grade CS (≥98% HPLC) validated against USP and EP reference standards for use as in-house reference material, HPLC system suitability testing, disaccharide compositional analysis calibration, and analytical method validation in QC laboratories.
Medical Device Coatings & Surface Modification
CS as biocompatible coating for implantable medical devices, cardiovascular stents, urinary catheters, and surgical meshes. Anti-thrombotic properties, reduced protein adsorption, improved hemocompatibility. ISO 13485 QMS supports medical device regulatory submissions.
Injectable Drug Delivery Systems & Sustained-Release Formulations
CS-based nanoparticles, microspheres, and in-situ gelling systems for sustained release of small molecules, proteins, and nucleic acid therapeutics. CS charge density enables electrostatic complexation; enzymatic degradability enables controlled in vivo release profiles.
Frequently Asked Questions
Injection-grade chondroitin sulfate sodium (CAS 9082-07-9) is a highly purified, sterile-filtered, pharmaceutical-grade glycosaminoglycan (GAG) biopolymer derived from bovine tracheal cartilage sourced exclusively from BSE-free countries (Australia, New Zealand, Brazil). Unlike food-grade or nutraceutical-grade chondroitin, injection-grade CS undergoes additional purification via anion-exchange chromatography (DEAE-Sepharose) to remove protein, DNA, and endotoxin, followed by ethanol precipitation, 0.22 μm sterile filtration, and lyophilization. The resulting product meets USP <2099> and EP 01/2025:2064 Injection-Grade monographs with endotoxins ≤0.5 EU/mg (LAL test) — a 100× stricter limit than food-grade (≤50 EU/mg). Primary pharmaceutical applications include: (1) Ophthalmic viscoelastic solutions (OVD) for cataract surgery, where CS protects the corneal endothelium during phacoemulsification (Viscoat®, DuoVisc®); (2) Intra-articular hyaluronic acid + CS combination injections for knee osteoarthritis viscosupplementation (Synvisc® + CS); (3) Wound healing and tissue engineering scaffolds (CS hydrogels for controlled drug release and regenerative medicine); (4) Pharmaceutical reference standards for analytical method validation and quality control. DMF Type II support is available for ANDA, 505(b)(2), and 510(k) regulatory filings.
The gap between injection-grade and food-grade chondroitin sulfate is defined by four critical quality parameters that make pharmaceutical CS a fundamentally different product. (1) Endotoxins: ≤0.5 EU/mg by LAL test for injection-grade versus ≤50 EU/mg for food-grade — a 100× difference. Ocular tissues are exquisitely sensitive to endotoxin; exceeding this limit risks TASS (Toxic Anterior Segment Syndrome), a severe sterile inflammatory condition causing permanent corneal damage. (2) Sterility (USP <71>): injection-grade must demonstrate zero microbial growth after 14-day incubation — a requirement absent from food-grade. (3) Particulate matter (USP <788>): injection-grade is tested for subvisible particulates (≥10 μm ≤6000/vial, ≥25 μm ≤600/vial) — critical for injectables where particulates cause embolic events or granulomatous inflammation. (4) Bioburden ≤10 CFU/g pre-sterilization — a GMP process-control parameter with no food-grade equivalent. Beyond these four, injection-grade CS requires anion-exchange chromatography purification (DEAE-Sepharose) to remove protein (≤1% vs up to 5% for food-grade), DNA, and endotoxin to injectable levels. The GMP (ICH Q7) manufacturing environment with validated cleaning, environmental monitoring, and full batch documentation creates the regulatory framework that food-grade facilities (21 CFR 111) cannot match. For any parenteral application, only injection-grade CS meeting USP <2099>/EP 01/2025:2064 with DMF Type II support is appropriate.
Chondroitin sulfate is a critical dispersive viscoelastic component in ophthalmic viscoelastic devices (OVDs) used during cataract phacoemulsification and other anterior segment procedures. During surgery, the surgeon must maintain anterior chamber depth while ultrasonic energy (40 kHz) breaks up the cataractous lens — creating simultaneous needs for mechanical space maintenance and tissue protection. CS functions as the dispersive viscoelastic: its lower molecular weight (20–50 kDa) and high charge density allow it to coat and adhere to the corneal endothelium through electrostatic interaction, forming a protective layer that absorbs and dissipates ultrasonic phacoemulsification energy. The clinical gold standard is the DuoVisc® soft-shell technique (Alcon): Viscoat® (3% sodium hyaluronate + 4% chondroitin sulfate — dispersive, endothelial protective coating) is injected first to coat the endothelium, followed by Provisc® (1% sodium hyaluronate — cohesive, space-maintaining) to maintain the anterior chamber. CS’s dispersive properties ensure it remains on the endothelium throughout the procedure, while HA’s cohesive properties provide the working space for safe instrument manipulation. Without CS, endothelial cell loss during cataract surgery is significantly higher, increasing the risk of postoperative corneal edema, delayed visual recovery, and long-term endothelial decompensation. The endotoxin limit of ≤0.5 EU/mg is non-negotiable for this application — ocular tissues lack robust endotoxin clearance, and even low-level contamination triggers TASS with permanent corneal damage.
Injection-grade chondroitin sulfate sodium is manufactured under a comprehensive pharmaceutical quality system: (1) GMP per ICH Q7 (Active Pharmaceutical Ingredient GMP) governing all aspects from raw material receiving through purification, sterile filtration, lyophilization, packaging, and release testing, with full batch records, deviation/CAPA systems, and annual product quality reviews. (2) DMF Type II (Drug Master File) filed with the US FDA containing complete CMC data: manufacturing process description, facilities and equipment, raw material specifications, impurity profiles (organic, inorganic, residual solvents per ICH Q3C), analytical methods and validation (HPLC, endotoxin LAL, particulate matter, sterility), reference standards, container closure system, stability data (25°C/60%RH and 40°C/75%RH per ICH Q1A), and batch analysis data. The DMF supports ANDA and 505(b)(2) filings via Letter of Authorization (LOA). (3) Monograph compliance: USP <2099> (Chondroitin Sulfate Sodium) and EP 01/2025:2064 (Natrii Chondroitini Sulfas) with full testing against all monograph parameters — identity, assay, endotoxins, particulate matter, sterility, protein, heavy metals, and disaccharide composition. (4) Additional regulatory: ISO 13485 (Medical Devices QMS) for CS used in OVD medical devices, FDA Facility Registration, and BSE/TSE-Free Certificate with country-of-origin traceability. Every shipment includes the complete pharmaceutical documentation package for regulatory submission support.
Every shipment of injection-grade chondroitin sulfate sodium includes: COA (HPLC purity ≥98.0%, full impurity profile, endotoxins ≤0.5 EU/mg by LAL test, particulate matter per USP <788>, sterility per USP <71>, bioburden ≤10 CFU/g, protein ≤1%, heavy metals per ICH Q3D: Pb ≤2 ppm / As ≤1 ppm / Hg ≤1 ppm / Cd ≤1 ppm / Co, V, Ni each ≤5 ppm, residual solvents per ICH Q3C, microbial limits per USP <61>/<62>), MSDS, HPLC Chromatogram (signed and dated, disaccharide composition), GPC Molecular Weight Distribution Report (20–50 kDa range confirmation), Disaccharide Composition Analysis (HPLC-UV after chondroitinase ABC digestion, Δdi-4S/Δdi-6S/Δdi-0S ratio), USP <2099> Monograph Compliance Certificate, EP 01/2025:2064 Monograph Compliance Certificate, DMF Type II Letter of Authorization (upon signed Confidentiality Agreement), GMP Certificate (ICH Q7), ISO 9001:2015 Certificate, ISO 13485 Certificate, FDA Facility Registration, BSE/TSE-Free Certificate (country-of-origin verified — Australia/New Zealand/Brazil), HALAL Certificate, KOSHER Certificate, Allergen Statement, Non-GMO Statement, Stability Data (2–8°C real-time 36-month and 25°C/60%RH accelerated 6-month per ICH Q1A), and Complete Lot Traceability from raw bovine tracheal cartilage to finished lyophilized product. Free sample available for qualified pharmaceutical buyers. MOQ: 100 g for evaluation; 1 kg for commercial orders. All documents provided in English.