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Specification Test Results
- Assay (alkalimetric, calculated on dried substance):98.0 - 100.5 %
- Assay (alkalimetric; dried substance):≥ 99.0 %
- Appearance of solution:passes test
- Identity:passes test
- Insoluble substances:≤ 0.2 %
- pH-value (1 %; water):4.2 - 4.8
- pH-value (2 %; water):4.2 - 4.6
- pH-value (5 %; water):4.2 - 4.5
- Carbonate:passes test
- Condensed phosphate:passes test
- Chloride (Cl):≤ 0.009 %
- Fluoride (F):≤ 0.0010 %
- Sulfate (SO₄):≤ 0.017 %
- Heavy metals (as Pb):≤ 0.0010 %
- Al (Aluminium):≤ 0.0005 %
- As (Arsenic):≤ 0.0001 %
- Cd (Cadmium):≤ 0.0001 %
- Fe (Iron):≤ 0.0010 %
- Hg (Mercury):≤ 0.0001 %
- Na (Sodium):≤ 0.1 %
- Pb (Lead):≤ 0.0001 %
- Residual solvents (ICH Q3C):excluded by manufacturing process
- Reducing substances:passes test
- Loss on drying (105 °C):≤ 0.5 %
- Loss on drying (130 °C):≤ 1.0 %
Specification Test Results
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Supplier: Edvotek
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Supplier: Edvotek
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Supplier: Avantor