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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%)
| 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. |
||
| 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