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Arthrospira maxima

Compositional guideline for 'Arthrospira maxima' permitted for use in listed medicines

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Name of the ingredient

Arthrospira maxima Setchell & Gardner (AHN)

Synonym

Spirulina maxima (Setchell & Gardner) Geitler

Definition of the ingredient

Arthrospira maxima is a photosynthetic, filamentous, spiral-shaped, multicellular cyanobacterium. The ingredient is a powder consisting of whole dried cells of A. maxima.

Table 1. Ingredient specific requirements
Test Method reference Acceptance criteria
Description
Appearance Visual A fine uniform powder, dark blue-green colour
Odour/Taste Organoleptic Mild seaweed taste, with no decayed or bitter taste or smell
Characteristics
Ash BP ≤ 12% w/w
Loss on drying BP < 8.0%
Identification
Microscopic Literature method1 Complies with authenticated reference specimen
Fatty acid composition GC2

Major fatty acids are

  • γ-linolenic acid (GLA), linoleic acid, palmitic acid and in some cases, oleic acid
  • α-linolenic acid (ALA) is ≤ 0.1%
Assay
Protein BP 55.0 - 70.0%
Iron BP - AAS 550 - 1800 mg/kg
β-carotene HPLC 700 - 2000 mg/kg
Chlorophyll UV 9 - 15 g/kg
Notes
  1. Tomaselli L, in Vonshak A (1997) Spirulina platensis (Arthrospira) Physiology, Cell Biology and Biotechnology, Spirulina platensis (Arthrospira) Taylor & Francis
  2. Otles S & Ruhsen (2001) Fatty acid composition of Chlorella and Spirulina Microalgae species, J AOAC International Vol 84, No 6, pp 1708-1713
Table 2. Incidental constituents
Test Method reference Acceptance criteria
Incidental metals and non-metals
Total heavy metals BP ≤ 10 ppm
Lead BP ≤ 2.5 ppm
Arsenic BP ≤ 1.0 ppm
Cadmium BP ≤ 0.5 ppm
Mercury BP ≤ 0.05 ppm
Foreign matter Ph Eur method 2.8.2 ≤ 2%
Microbiology
While substance manufacturers are encouraged to include limits for objectionable microorganisms, it is the product into which the substance is 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, must comply with the microbial acceptance criteria set by Clause 9 of the Order.

Key to abbreviations

AAS = Atomic absorption spectroscopy

AOAC = Association of Official Analytical Chemists

BP = British Pharmacopoeia

GC = Gas chromatography

HPLC = High-pressure liquid chromatography

Ph Eur = European Pharmacopoeia

UV = Ultra violet

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