Alginate-konjac-xanthan polysaccharide complex
Compositional guideline for 'Alginate-konjac-xanthan polysaccharide complex' permitted for use in listed medicines
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Name of the ingredient
Alginate-konjac-xanthan polysaccharide complex (AAN)
Definition of the ingredient
Alginate-konjac-xanthan polysaccharide complex is a polysaccharide complex resulting from the combination of konjac flour (70%), xanthan gum (17%) and sodium alginate (13%) in a fluidised bed reactor using heat and water followed by granulation.
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Characteristics | ||
| Identification | ||
| Assay | ||
| Appearance | Visual | Off-white to light tan granular powder |
| Odour | Organoleptic | Characteristic |
| Loss on drying (135 °C, 6 h) | FCC10, Appendix IIc | Not more than 10 % w/w |
| Absence of konjac flour | FCC10 | Conforms |
| Absence of sodium alginate | FCC10 | Conforms |
| Absence of xanthan gum | FCC10 | Conforms |
| Viscosimetric characterisation | FCC10 | Conforms |
| Sodium | USP | Conforms |
| IR | USP | Conforms with authenticated reference material/IR spectrum |
| Viscosity over time | FCC10 | Viscosity at 10 min: 800 – 10 900 cP Viscosity at 60 min: 16 400 – 42 200 cP Viscosity at 120 min: 22 700 – 45 000 cP |
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Residual Solvents | ||
| Incidental metals and non-metals | ||
| Pesticide residues and environmental contaminants: (including agricultural and veterinary substances) | ||
| Microbiology | ||
| Residual Solvents | BP 2016 (Appendix VIII L) | Meets the requirements of the BP |
| While ingredient manufacturers are encouraged to include limits for Incidental metals and non-metals, it is the product into which those substances are formulated that contains the ingredient, alone or in combination with other ingredients, must comply with the acceptance criteria set in the United States Pharmacopeia - National Formulary (USP-NF) general chapter ' Elemental Contaminants in Dietary Supplements'. When testing is performed at the raw material stage, calculation of the total daily exposure in the finished product should be performed. This calculation is based on the quantity of each ingredient present in the product, the maximum potential contamination given the proposed limits for each raw material and the daily dose of the product. | ||
| Pesticide Residues | USP | Complies |
| While substance manufacturers are encouraged to include limits for objectionable microorganisms, it is the product into which those substances are 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 that contains the ingredient, alone or in combination with other ingredients, must comply with the microbial acceptance criteria set by Clause 9 of the Order. | ||
Key to abbreviations
BP = British Pharmacopoeia
FCC = Food Chemical Codex
IR = Infrared spectrophotometry
USP = United States Pharmacopoeia
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