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Name of the ingredient
Larix arabinogalactan (AAN)
Definition of the ingredient
Larix arabinogalactan is a highly branched polysaccharide derived from Larix occidentalis (Western larch) or Larix laricina (Eastern larch) wood by extraction with water. The ratio of galactose and arabinose subunits occurring in the substance is approximately 6:1.
Molecular formula (nominal): [(C5H8O4)(C6H10O5)6]x
Molecular mass range: 15000-60000
Cas Number: 9036-66-2
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Free flowing powder | Visual | Complies |
| Colour | Visual | White to light brown |
| Odour | Organoleptic | Pine |
| Characteristics | ||
| Bulk density | USP <616> | 0.27 - 0.40 g/mL |
| Viscosity (30%) | Ph Eur method 2.2.8 | ≤ 15 mPas |
| Loss on drying | Ph Eur method 2.2.32 | ≤ 6.0% |
| Solubility in water | BP (General notice) | Freely soluble in water |
| Identification | ||
| Test 1: IR | Ph Eur method 2.2.24 | IR and 1H-NMR spectra comply with those of authenticated references |
| Test 2: 1H-NMR | NMR | |
| Assay | ||
| Polysaccharides (as arabinogalactan) | HPLC | ≥ 85.0% |
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Incidental metals and non-metals | ||
| Total heavy metals | USP <231>; Ph Eur method 2.4.8 | ≤ 5 ppm |
| Lead | USP <730>; Ph Eur method 2.2.57 | ≤ 0.1 ppm |
| Arsenic | USP <730> | ≤ 0.4 ppm |
| Cadmium | ≤ 0.25 ppm | |
| Mercury | ≤ 0.3 ppm | |
| Pesticide residues and environmental contaminants: (including agricultural and veterinary substances) |
BP (Appendix XI L); Ph Eur method 2.8.13 | Complies |
| Other organic or inorganic impurities or toxins | ||
| Ash | AOAC 923.03 | ≤ 12.0% |
| Related substances: | ||
| Fat | AOAC 922.06 / 920.85 | ≤ 1.0% |
| Protein | AOAC 930.29 / 991.20 | ≤ 0.3% |
| Phenolics | Not specified - an appropriately validated method should be used | ≤ 2.0% |
| 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 which 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
AOAC = Association of Analytical Communities
BP = British Pharmacopoeia
mPas = millipascal second
HPLC = High-pressure liquid chromatography
IR = Infrared spectrophotometry
1H-NMR = Nuclear magnetic resonance spectroscopy
Ph Eur = European Pharmacopoeia
USP = United States Pharmacopoeia