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Compositional guideline: Calcium pyruvate

21 September 2015

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)

Table 1. Ingredient specific requirements
Test Method reference Acceptance criteria
Description
Appearance (Colour) Visual White to cream coloured powder
Characteristics

Loss on drying

  • anhydrous
  • pentahydrate
BP (Appendix IX D)

 

  • Not more than 0.5% w/w
  • 29.1% - 30.1% w/w
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
Table 2. Incidental constituents
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' 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