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Sodium chondroitin sulfate derived from fermentation of Escherichia coli

Compositional guideline for 'sodium chondroitin sulfate derived from fermentation of Escherichia coli' permitted for use in listed medicines

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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.

Table 1. Ingredient specific requirements
TestMethod referenceAcceptance criteria
Description
Characteristics
Identification
Assay
AppearanceVisualWhite to off-white powder
Clarity and Colour of SolutionUSP Chondroitin Sulfate Sodium≤0.35
Specific optical rotation (°) [3% aqueous solution]USP <781S>– 2⁰ to – 12⁰ (dried basis)
Loss on dryingUSP <731>≤10.0 %
Residue on ignitionUSP <281>20.0 to 30.0% (dried basis)
pH [1% aqueous solution]USP <791>5.5 to 7.5
Intrinsic viscosityPh. Eur. sodium chondroitin sulfate0.01 to 0.15 m3/kg
InfraredUSP <197K>The spectra of the sample matches with the corresponding reference standard
SodiumUSP <191>Complies
sodium chondroitin sulfate content (% anhydrous basis)USP sodium chondroitin sulfate95.0 to 105.0 %
Table 2. Incidental constituents
TestMethod referenceAcceptance 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 MetalsUSP <231>, Method II≤20 ppm
Related substances (any individual impurity)USP Chondroitin Sulfate Sodium (electrophoretic purity)≤2.0 %
Limit for proteinUSP Chondroitin Sulfate Sodium≤0.5 % (dry basis)
ChlorideUSP <221>≤0.50 %
SulfateUSP <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

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