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Compositional guideline: Calcified Lithothamnion species

12 July 2019

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 Oranoleptic Odourless
Characteristics
Solubility BP (General notices) Practically insoluble in water
Ash FCC NLT 90 % w/w
Loss on drying FCC NMT 5 % w/w
Identification
Calcium ICP-OES Complies
Magnesium ICP-OES Complies
Carbonates Ph Eur method 2.3.1 Complies
Assay
Calcium ICP-OES NLT 32 % w/w
Magnesium ICP-OES NLT 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
Lead ICP-OES NMT 1 ppm
Arsenic ICP-OES NMT 1.5 ppm
Cadmium ICP-OES NMT 1 ppm
Mercury ICP-OES NMT 0.1 ppm
Bromides ICP-OES NMT 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. 100 '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 11 of the Order.

Key to abbreviations

BP = British Pharmacopoeia

Ph Eur = European Pharmacopoeia

FCC = Food Chemical Codex

NLT = Not less than

NMT = Not more than

ICP-OES = Inductively coupled plasma optical emission spectrometry