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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' - external site 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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