Compositional guideline: Demineralised fish proteoglycan extract
Definition
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 meets the requirements shown in the following table and has a shelf life of not more than 24 months when stored in appropriate packaging under ambient conditions.
| Test | Limits | Method |
|---|---|---|
| Appearance: | A free flowing yellow powder with a smell of fish | |
| Protein | 37-50% | Lowry's method |
| Residue on Ignition | 5.0 - 15.0% | USP |
| Loss on Drying | < 8.0% | Ph. Eur. |
| Fat | ≤ 1.0% | Gravimetric method |
| Mucopolysaccharides | 47 - 63% present as* Chondroitin-6-sulfate (55%), Chondroitin-4-sulfate (27%) and keratan sulfate (18%) |
ICP** for routine analysis following establishment by ion exchange chromatography and 13C- NMR OR HPLC** |
| pH | 5.5 - 7.5 | Potentiometric |
| Total heavy metals | ≤ 20 mg/kg | USP |
| Lead | 0.5 mg/kg | USP |
| Arsenic | 1.0 mg/kg as inorganic arsenic | HPLC/ICP-MS |
| Mercury | 1.0 mg/kg | ICP-MS |
| Residual enzyme activity | nil | |
| Microbial Requirements | According to AGRD2*** | |
| * nominal composition, determined by ion-exchange HPLC ** Determined as sodium chondroitin sulfate based on sulfur determination. *** Finished products incorporating this substance must comply with the specific microbial limits in the Australian Guidelines for the Registration of Drugs, Volume 2. † Sponsors using this substance in products must ensure that their products conform with the requirements of relevant State and Federal protected species legislation. |
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