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Compositional guideline: Chondroitin Sulphate Sodium derived from fermentation of Escherichia coli

13 July 2021

Name of the ingredient

Chondroitin sulphate sodium (AAN)

Definition of the ingredient

Chondroitin sulphate sodium 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.

Table 1. Ingredient specific requirements
Test Method reference Acceptance criteria
Description
Appearance Visual White to off-white powder
Characteristics
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. Chondroitin Sulfate Sodium 0.01 to 0.15 m3/kg
Identification
Infrared USP <197K> The spectra of the sample matches with the corresponding reference standard
Sodium USP <191> Complies
Assay
Chondroitin sodium sulphate content (% anhydrous basis) USP Chondroitin Sulfate Sodium 95.0 to 105.0 %
Table 2. Incidental constituents
Test Method reference Acceptance criteria
Incidental metals and non-metals
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
Other organic or inorganic impurities or toxins
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