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Quality standard:
Items | Standard | Result | |||||
BP2012 | Appearance | White or almost white, crystalline powder or colourless crystals | White crystalline powder | ||||
PH | 2.7-3.3 | 3.1 | |||||
Water | ≤5.0% | 2.25% | |||||
Sulphated ash | ≤0.1% | 0.01% | |||||
Sulphates | ≤300ppm | <300ppm | |||||
Heavy metals | ≤20ppm | <20ppm | |||||
Related substances | |||||||
—Any impurity | ≤0.4% | <0.05% | |||||
—Total impurities | ≤1.0% | <0.05% | |||||
Assay | 98.5-101.0% | 99.7% | |||||
USP36 | Identification | A: IR absorption; B: Tests of Chloride | Comply | ||||
Absorbance of solution | ≤0.025% | 0.017 | |||||
Limit of nitrate | No brown ring produced at the junction of the two layers | Comply | |||||
PH | 2.7-3.4 | 3.2 | |||||
Water | ≤5.0% | 2.34% | |||||
Residue on ignition | ≤0.2% | 0.01% | |||||
Chromatographic purity | ≤1.0% | 0.23% | |||||
Residual solvent | |||||||
—Methanol | ≤0.3% | 0.05% | |||||
—Ethanol | ≤0.5% | <0.01% | |||||
Assay | 98.0-102.0% | 99.6% | |||||
Conclusions | This batches complies with the specification of BP2012 and USP36 |