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Name of the ingredient
Calcium pyruvate (AAN)
Definition of the ingredient
IUPAC name: Propanoic acid, 2-oxo-, calcium salt
Molecular formula: Ca(C3H3O3)2 (anhydrous) Ca(C3H3O3)2 · 5 H2O (pentahydrate)
Molecular mass: .19 g/mol (anhydrous) 304 g/mol(pentahydrate)
CAS Number: 52009-14-0 (anhydrous) 1707-07-4 (pentahydrate)
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Appearance (Colour) | Visual | White to cream coloured powder |
| Characteristics | ||
|
Loss on drying
|
BP (Appendix IX D) |
|
| Identification | ||
| Calcium pyruvate |
BP (Appendix II A) Infra-red spectrum |
Complies with authenticated reference material/IR spectrum |
| Calcium | BP Appendix VI | Complies |
| Assay | ||
| Calcium | Complexometric titration, BP (Appendix VIII D) | 18.3 - 19.1% w/w on anhydrous basis |
| Pyruvate | HPLC, BP (Appendix III D) | 79.7 - 82.9% w/w, on anhydrous basis |
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Residual solvents | ||
| Residual Solvent | BP (Appendix VIII L and Supplementary Chapter SC IV D) | Complies |
| Incidental metals and non-metals | ||
| While ingredient manufacturers are encouraged to include limits for Incidental metals and non-metals, it is the product into which those substances are formulated that contains the ingredient, alone or in combination with other ingredients, must comply with the acceptance criteria set in the United States Pharmacopeia - National Formulary (USP-NF) general chapter '<2232> Elemental Contaminants in Dietary Supplements'. When testing is performed at the raw material stage, calculation of the total daily exposure in the finished product should be performed. This calculation is based on the quantity of each ingredient present in the product, the maximum potential contamination given the proposed limits for each raw material and the daily dose of the product. | ||
| 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