You are here

Compositional guideline: Poliglusam derived from Aspergillus niger

14 December 2016

Name of the ingredient

Poliglusam derived from Aspergillus niger (AAN)

Synonym: Chitosan derived from Aspergillus niger

Definition of the ingredient

Poliglusam (2-Amino-2-deoxy-poly-D-glucosamine) is an insoluble, non-digestible fibre preparation derived from the cell walls of non-genetically modified Aspergillus niger mycelium. Poliglusam derived from Aspergillus niger contains not more than 15% beta-glucan.

Molecular formula: (C6H11NO4)n, (C6H10O5)n

Table 1: Ingredient specific requirements
Test Method reference Acceptance criteria
Description
Appearance Visual Fine free-flowing powder
Colour Visual Off-white to slightly brownish
Odour Organoleptic Odourless
Characteristics
Loss on drying Ph Eur 2.2.32 Not more than 10 % w/w
Viscosity 1% in acetic acid 1% Ph Eur 2.2.10 2.5-15 mPa.s
Degree of acetylation Ph Eur 2.2.20 0 to 30 mol%
Tapped density Ph Eur 2.9.34 0.7-1.0 g/cm3
Identification
Chitosan Fourier Transform Infrared Spectrum (Ph Eur 2.2.24) Matches spectrum of authenticated Ph Eur Reference standard
Assay
Chitosan Content determined by calculation Not less than 80% w/w
Glucan Ph Eur 2.2.25 Not more than 15% w/w
Table 2: Incidental constituents
Test Method reference Acceptance criteria
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.
Other organic or inorganic impurities or toxins
Ash Ph Eur 2.4.16 Not more than 3 % w/w
Protein Derivatisation and reaction with ninhydrin prior to analysis according to Ph Eur 2.2.25 Not more than 2 % w/w
Aflatoxin B1 Samples are extracted in an acetonitrile/water mixture, and the filtered extract is purified on an imunoaffinity column and then analysed by LC/MS/MS. [1][2] Not more than 0.5 µg.kg-1
Aflatoxin B2 Not more than 0.5 µg.kg-1
Aflatoxin G1 Not more than 0.5 µg.kg-1
Aflatoxin G2 Not more than 1 µg.kg-1
Ochratoxin A Not more than 1 µg.kg-1
Fumonisin B1 Samples are extracted by a methanol/water/acetonitrile mixture and the filtered extract is purified on an immunoaffinity column. Analysis is then conducted using LC/MS/MS against 13C- internal standards. [3] Not more than 1 µg.kg-1
Fumonisin B2 Not more than 100 µg.kg-1
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.
Notes
  1. Methods derived from those described in Krska, R. (1998), Journal of Chromatography A, 815 (1), 49-57.
  2. Methods derived from Biselli, Hartig, Wegner & Hummert (2005), LC GC Europe, 20 (2), 20-32.
  3. Method based on NF EN 14352 European norm- December 2004.

Key to abbreviations

HPLC = High-pressure liquid chromatography

LC/MS/MS = Liquid Chromatography-Tandem Mass Spectrometry

Ph Eur = European Pharmacopoeia