Sub menu

 

 

Arthrospira maxima

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

Last updated

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
TestMethod referenceAcceptance criteria
Description
Characteristics
Identification
Assay
Notes
AppearanceVisualA fine uniform powder, dark blue-green colour
Odour/TasteOrganolepticMild seaweed taste, with no decayed or bitter taste or smell
AshBP≤ 12% w/w
Loss on dryingBP< 8.0%
MicroscopicLiterature method1Complies with authenticated reference specimen
Fatty acid compositionGC2

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%
ProteinBP55.0 - 70.0%
IronBP - AAS550 - 1800 mg/kg
β-caroteneHPLC700 - 2000 mg/kg
ChlorophyllUV9 - 15 g/kg
  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
TestMethod referenceAcceptance criteria
Incidental metals and non-metals
Microbiology
Total heavy metalsBP≤ 10 ppm
LeadBP≤ 2.5 ppm
ArsenicBP≤ 1.0 ppm
CadmiumBP≤ 0.5 ppm
MercuryBP≤ 0.05 ppm
Foreign matterPh Eur method 2.8.2≤ 2%
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

Print version

Product types