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Name of the ingredient
Calcium L-threonate (AAN)
Definition of the ingredient
(2R,3S)-2,3,4-trihydroxybutyric acid hemicalcium salt; L-Threonic acid calcium salt
Molecular formula: CaC8H14O10
Molecular mass: 310.27
CAS Number: 70753-61-6
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Appearance | Visual | White powder |
| Characteristics | ||
| Solubility | BP (General notice) | Soluble in water |
| Appearance of solution (5% aqueous solution) | Ph Eur method 2.2.1 and 2.2.2, Method II | Clear and colourless |
| pH (5% aqueous solution) | Ph Eur method 2.2.3 | 6.0 - 8.0 |
| Specific optical rotation (5% aqueous solution) | Ph Eur method 2.2.7 | +13.0° to +14.3° |
| Loss on drying | Ph Eur method 2.2.32 | Not more than 1.5% w/w |
| Identification | ||
| Calcium L- threonate |
Ph Eur method 2.2.24 (IR) |
Complies with authenticated reference standard |
| Threonic acid |
Ph Eur method 2.2.24 (IR) |
Complies with authenticated reference standard |
| Calcium |
Ph Eur method 2.3.1 (Qualitative reaction and tests) |
Positive |
| Assay | ||
| Calcium | Ph Eur method 2.5.11 | 12.7 - 13.2% w/w, on dried basis |
| Threonic acid | Capillary Electrophoresis - Indirect UV detection | 85.8 - 88.4% w/w, on dried basis |
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Other organic or inorganic impurities or toxins | ||
| Residual solvents | USP (467) | Complies |
| Carbonates |
Ph Eur method 2.3.1 (Qualitative reaction and tests) |
Negative |
| Ascorbic acid | HPLC | Not more than 0.1% w/w |
| Incidental metals and non-metals | ||
| Heavy metals (as lead) | Ph Eur method 2.4.8 | Not more than 10 ppm |
| Iron | Ph Eur method 2.4.8 | Not more than 100 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' - external site 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
BP = British Pharmacopoeia
HPLC = High performance liquid chromatography
IR = Infrared
Ph Eur = European Pharmacopoeia
USP = United States Pharmacopeia
UV = Ultra violet