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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 | ||
| Characteristics | ||
| Identification | ||
| Assay | ||
| Appearance | Visual | White powder |
| 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 |
| 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 |
| 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 | ||
| Incidental metals and non-metals | ||
| Microbiology | ||
| 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 |
| 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 |
| 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
BP = British Pharmacopoeia
HPLC = High performance liquid chromatography
IR = Infrared
Ph Eur = European Pharmacopoeia
USP = United States Pharmacopeia
UV = Ultra violet