We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
Name of the ingredient
sodium chondroitin sulfate (AAN)
Definition of the ingredient
sodium chondroitin sulfate derived from fermentation of Escherichia coli is a product of the sulphation of chondroitin (a ubiquitous heteropolysaccharide) isolated from a fermentation process and is a mixture of polysaccharides in which the major components are the mono-sulphated species with substitution primarily at the 4- or 6- position of N acetyl-galactosamine and is analogous to chondroitin sulphate isolated from traditional animal cartilage.
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Characteristics | ||
| Identification | ||
| Assay | ||
| Appearance | Visual | White to off-white powder |
| Clarity and Colour of Solution | USP Chondroitin Sulfate Sodium | ≤0.35 |
| Specific optical rotation (°) [3% aqueous solution] | USP <781S> | – 2⁰ to – 12⁰ (dried basis) |
| Loss on drying | USP <731> | ≤10.0 % |
| Residue on ignition | USP <281> | 20.0 to 30.0% (dried basis) |
| pH [1% aqueous solution] | USP <791> | 5.5 to 7.5 |
| Intrinsic viscosity | Ph. Eur. sodium chondroitin sulfate | 0.01 to 0.15 m3/kg |
| Infrared | USP <197K> | The spectra of the sample matches with the corresponding reference standard |
| Sodium | USP <191> | Complies |
| sodium chondroitin sulfate content (% anhydrous basis) | USP sodium chondroitin sulfate | 95.0 to 105.0 % |
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Incidental metals and non-metals | ||
| Other organic or inorganic impurities or toxins | ||
| Lead (as Pb) | USP <233> | ≤0.5 ppm |
| Arsenic (as As) | USP <233> | ≤1.5 ppm |
| Cadmium (as Cd) | USP <233> | ≤0.5 ppm |
| Mercury (as Hg) | USP <233> | ≤0.1 ppm |
| Heavy Metals | USP <231>, Method II | ≤20 ppm |
| Related substances (any individual impurity) | USP Chondroitin Sulfate Sodium (electrophoretic purity) | ≤2.0 % |
| Limit for protein | USP Chondroitin Sulfate Sodium | ≤0.5 % (dry basis) |
| Chloride | USP <221> | ≤0.50 % |
| Sulfate | USP <221> | ≤0.24 % |
| Tetrabutylammonium (TBA) | GC | ≤50 ppm |
| Dimethylformamide (DMF) | GC | ≤3 ppm |
Key to abbreviations
GC = Gas chromatography
Ph. Eur. = European Pharmacopoeia
USP = United States Pharmacopoeia