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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.
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Appearance | Visual | Fine off-white powder |
| Odour | Organoleptic | 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 |
| 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