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Compositional guideline: Demineralised fish proteoglycan extract

27 April 2011

Name of the ingredient

Demineralised fish proteoglycan extract (AAN)

Definition of the ingredient

Demineralised fish proteoglycan extract is obtained from species of the order Selachii. The substance is the end product of an extraction process involving aqueous extraction at elevated temperature and partial hydrolysis by food- or pharmacopoeial-grade proteases. The bulk anhydrous substance has a shelf life of not more than 24 months when stored in appropriate packaging under ambient conditions. The mucopolysaccharide components of the proteoglycan (determined by ion-exchange HPLC) nominally comprised chondroitin-6-sulfate (55%), chondroitin-4-sulfate (27%) and keratin sulphate (18%)

Table 1. Ingredient specific requirements
Test Method reference Acceptance criteria
Description
Appearance Visual Free flowing yellow powder
Odour Organoleptic Smell of fish
Characteristics
Residue on ignition USP 5.0 - 15.0%
Loss on drying Ph Eur < 8.0%
pH Potentiometric 5.5 - 7.5
Identification
Unsaturated disaccharide profile obtained after enzymatic hydrolysis HPLC Profile matches that of a reference
Assay
Fat Gravimetric method ≤ 1.0%
Protein Lowry's method 37 - 50%
Mucopolysaccharides ICP for routine analysis following establishment by ion exchange chromatography and 13C-NMR or HPLC* 47 - 63%

Notes

**Determined as sodium chondroitin sulphate based on sulfur determination.

Table 2. Incidental constituents
Test Method reference Acceptance criteria
Solvent residues
Residual enzyme activity nil
Incidental metals and non-metals
Total heavy metals USP ≤ 20 ppm
Lead USP 0.5 ppm
Arsenic HPLC/ICP-MS 1 ppm as inorganic arsenic
Mercury ICP-MS 1 ppm
Microbiology While substance manufacturers are encouraged to include limits for objectionable microorganisms, it is the product into the substance is formulated that is subject to a legally binding set of criteria. The Therapeutic Goods Order No. 77 'Microbiological Standards for Medicines' mandates that any finished product which contains the ingredient, alone or in combination, must comply with the microbial acceptance criteria set by Clause 9 of the Order.

Note: Sponsors using this substance in products must ensure that their products comply with the requirements of relevant State and Federal protected species legislation.

Key to abbreviations

13C-NMR = 13Carbon-Nuclear magnetic resonance

HPLC = high-pressure liquid chromatography

ICP-MS = Inductively coupled plasma mass spectrometry

Ph Eur = European Pharmacopoeia

USP = United States Pharmacopoeia

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