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Compositional guideline: Alginate-konjac-xanthan polysaccharide complex

1 February 2017

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.

Table 1: Ingredient specific requirements
Test Method reference Acceptance criteria
Description
Appearance Visual Off-white to light tan granular powder
Odour Organoleptic Characteristic
Characteristics
Loss on drying (135 °C, 6 h) FCC10, Appendix IIc Not more than 10 % w/w
Identification
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
Assay
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
Table 2: Incidental constituents
Test Method reference Acceptance criteria
Residual Solvents
Residual Solvents BP 2016 (Appendix VIII L) Meets the requirements of the BP
Incidental metals and non-metals
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 and environmental contaminants: (including agricultural and veterinary substances)
Pesticide Residues USP Complies
Microbiology
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