Compositional guideline: Calcified Lithothamnion species

8 November 2016

Name of the ingredient

Calcified Lithothamnion species (AAN)

and

Calcified Lithothamnion tophiforme (AAN)

Definition of the ingredient

The substance is the skeletal deposits of Lithothamnion spp. (L. corallioides, L. tophiforme) sourced from the Atlantic Ocean. It is washed, dried and milled.

For the ingredient 'Calcified Lithothamnion tophiforme':

The substance is the skeletal deposits of Lithothamnion tophiforme sourced from Arnarfjordur in Iceland. It is washed, bleached, dried and milled.

Table 1: Ingredient specific requirements
Test Method reference Acceptance criteria
Description
Appearance Visual Fine off-white powder
Odour Organoleptic Odourless
Characteristics
Solubility BP (General notice) Practically insoluble in water
Ash FCC Not less than 90% w/w
Loss on drying FCC Not more than 5% w/w
Identification
Calcium AAS Complies
Magnesium AAS Complies
Carbonates Ph Eur method 2.3.1 Complies
Assay
Calcium AAS Not less than 32% w/w
Magnesium AAS Not less than 2.2% w/w
Carbon ICP-OES 11-15% w/w
Table 2: Incidental constituents
Test Method reference Acceptance criteria
Incidental metals and non-metals
Heavy metals (as lead) USP <231> Not more than 10 ppm
Arsenic FCC Not more than 1.0 ppm
Cadmium BP (Appendix VII) Not more than 0.5 ppm
Mercury BP (Appendix VII) Not more than 0.1 ppm
Bromides IC or ICP-OES Not more than 10 ppm
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.

Key to abbreviations

AAS = Atomic absorption spectroscopy

BP = British Pharmacopoeia

FCC = Food Chemical Codex

IC = Ion chromatography

ICP-OES = Inductively-coupled plasma optical emission spectrometry

ISO = International Standards Organisation

Ph Eur = European Pharmacopoeia

USP = United States Pharmacopoeia