Specifications
Test Parameter | Ph.Eur | USP-NF | E341(iii) | FCC | ||
Appearance | White or almost white powder |
White or almost white powder |
White or almost white powder |
Occurs as a white powder |
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Identification A | Passes test | Passes test | Passes test | Passes test | ||
Identification B | Passes test | Passes test | Passes test | Passes test | ||
Identification C | It complies with the limits of the assay |
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Assay【as Ca】 | 35.0%~40.0% | 34.0%~40.0% | 34.0%-40.0% | |||
Assay【ignited basis】 |
≥90.0% | |||||
P2O5 | 38.5-48.0% | |||||
Loss on ignition | ≤8.0% | ≤8.0% | ≤8.0% | ≤10.0% | ||
Heavy metal(as Pb) | ≤0.003% | |||||
Mercury | ≤1.0ppm | |||||
Arsenic | ≤4.0ppm | ≤3.0ppm | ≤1.0ppm | ≤3.0ppm | ||
Lead | ≤1.0ppm | ≤2.0ppm | ||||
Cadmium | ≤1.0ppm | |||||
Aluminium | ≤150.0ppm | |||||
Chloride | ≤0.15% | ≤0.14% | ||||
Sulfate | ≤0.5% | ≤0.8% | ||||
Water-soluble substances |
≤0.5% | |||||
Acid-insoluble substances |
≤0.2% | ≤0.2% | ||||
Carbonate | To pass the test | |||||
Barium | To pass the test | |||||
Dibasic salt and calcium oxide |
To pass the test | |||||
Limit of fluoride | ≤75.0ppm | ≤75.0ppm | ≤50.0ppm | ≤75.0ppm | ||
Iron | ≤400.0ppm | |||||
Particle size: Fine powder (D50) |
2.0-4.0 microns | Not a compendial specification | ||||
6.0-9.0 microns | Not a compendial specification | |||||
10.0-12.0 microns | Not a compendial specification | |||||
Thru 325 mesh | ≥95.0% | Not a compendial specification | ||||
Granular | Not a compendial specification | |||||
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