The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Name of the ingredient
Calcium fructoborate tetrahydrate (Australian Approved Name #138481).
Definition of the ingredient
Calcium fructoborate tetrahydrate is a calcium salt tetrahydrate of a bis(fructose) ester of boric acid in the form of a powder, represented by Ca[(C6H10O6)2B]2•4H2O, with a molecular mass of 846 Da.
Calcium fructoborate tetrahydrate is produced by chemical synthesis whereby fructose is combined with boric acid in water to produce a bis(fructose) ester of boric acid through various heating and mixing processes. Calcium carbonate is then added to produce a solution containing the calcium salt of fructoborate (tetrahydrate). The solution is freeze-dried, ground to produce the final powdered product, and then packaged and stored under representative storage conditions (22 ± 1°C RH 55-60 %).
Chemical Abstract Service (CAS) Number: 2247559-29-9
Table 1. Ingredient specific requirements
Test | Method reference | Acceptance criteria |
|---|---|---|
Description | ||
Characteristics | ||
Identification | ||
Assay | ||
Appearance | Visual | White powder |
Free moisture | AOAC 925.09 and 926.08 | ˂ 5.0% |
Ash | AOAC 923.03M – at 1,000°C | 15 to 16% |
Chemical ‘fingerprint’ | FT-IR[1] | Sample correlation result is ≥ 0.90 relative to reference sample |
Calcium | AOAC 985.01 | 4.5 to 5.0% |
Boron | AOAC 985.01 | 2.5 to 2.7% |
Fructose | AOAC 988.12 | 80 to 85% |
Table 2. Incidental constituents
Test | Method reference | Acceptance criteria |
|---|---|---|
Incidental metals and non-metals | ||
Microbiology | ||
Arsenic | AOAC 993.14M | ≤ 1 mg/kg |
Cadmium | AOAC 993.14M | ≤ 0.1 mg/kg |
Lead | AOAC 993.14M | ≤ 0.1 mg/kg |
Mercury | AOAC 993.14M | ≤ 0.03 mg/kg |
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. | ||
Footnote
[1] FT-IR: FT-IR spectrometer with OMNIC spectroscopy software; Attenuated Total Reflectance accessory with diamond/ZnSe single bounce top plate; wave number range of 400 to 4,000 cm-1, minimum 32 scans, and 4.00 cm-1 resolution.
Key to abbreviations:
AOAC = Association of Official Analytical Chemists
FT-IR = Fourier-transform infrared spectroscopy