description
Item | Unit | Quality Standards | Analysis Results |
Characters | — | White or almost while, crystalline powder, colourless crystals or granules. Odorless, has a strongly acid taste, effloresces in dry air. Very soluble in water, freely soluble in ethanol. | Pass |
Identification | — | Pass Test | Pass |
Appearance of solution | — | Pass Test | Pass |
Assay | % | 99.5~100.5 | 99.9 |
Water | % | 7.5~8.8 | 8.64 |
Readily Carbonisable Substances | — | Pass Test | Pass |
Sulphated Ash (Residue on Ignition) | % | ≤0.05 | 0.02 |
Sulfate | mg/kg | ≤150 | <150 |
Oxalate | mg/kg | ≤100 | <100 |
Lead | mg/kg | ≤0.5 | <0.05 |
Arsenic | mg/kg | ≤1.0 | <0.3 |
Mercury | mg/kg | ≤1.0 | <0.5 |
Aluminium | mg/kg | ≤0.2 | <0.2 |
Heavy Metals | mg/kg | ≤5.0 | <5.0 |
Bacterial endotoxins | IU/mg | ≤0.5 | <0.5 |
Conclusion: The product is in comformity with BP/USP/FCC/E330. | |||
Item | Unit | Quality Standards | Analysis Results |
Characters | — | White or almost while, crystalline powder, colourless crystals or granules. Odorless, has a strongly acid taste, effloresces in dry air. Very soluble in water, freely soluble in ethanol. | Pass |
Identification | — | Pass Test | Pass |
Appearance of solution | — | Pass Test | Pass |
Assay | % | 99.5~100.5 | 99.8 |
Water | % | ≤0.5 | 0.13 |
Readily Carbonisable Substances | — | Pass Test | Pass |
Sulphated Ash (Residue on Ignition) | % | ≤0.05 | 0.02 |
Sulfate | mg/kg | ≤150 | <150 |
Oxalate | mg/kg | ≤100 | <100 |
Lead | mg/kg | ≤0.5 | <0.2 |
Arsenic | mg/kg | ≤1.0 | <0.1 |
Mercury | mg/kg | ≤1.0 | <0.5 |
Aluminium | mg/kg | ≤0.2 | <0.2 |
Heavy Metals | mg/kg | ≤5.0 | <5.0 |
Bacterial endotoxins | IU/mg | <0.5 | <0.5 |
Conclusion: The product is conformity with BP/USP/FCC/E330. | |||
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