CERTIFICATE OF ANALYSIS | ||||
Analysis Contents | Analysis Standard | Analysis Results | ||
Characteristics | White or almost White | Pass | ||
Identification | Positive Reaction | Positive | ||
Melting Point | About 190℃ | 190.2℃ | ||
PH | 2.1-2.6 | 2.41 | ||
Clarity Of Solution | Clear | Clear | ||
Colour Of Solution | ≤BY7 | <BY7 | ||
Copper | ≤5ppm | <5ppm | ||
Heavy Metals | ≤10ppm | <10ppm | ||
Mercury | ≤1ppm | <1ppm | ||
Lead | ≤2ppm | <2ppm | ||
Arsenic | ≤3ppm | <3ppm | ||
Oxalic Acid | ≤0.2% | <0.2% | ||
Iron | ≤2ppm | <2ppm | ||
Loss of Drying | ≤0.4% | <0.04% | ||
Sulphate Ash(Residue On Ignition) | ≤0.1% | <0.04% | ||
Specific Optical Rotation | +20.5°–+21.5° | +21.21° | ||
Impurity E | ≤0.2% | 0.12% | ||
mesh | 40-80mesh | pass | ||
Related Substances | Impurity C;D | ≤0.15% | 0.11% | |
Unspecified Impurities | 0.1% max | 0.05% | ||
Total | 0.2% max | 0.11% | ||
Disregard limit | 0.05% max | 0.05% | ||
Organic Volatile Impurities | Pass | Pass | ||
Assay(Purity) | 99.0%-100.5% | 99.80% | ||
Conclusion | The Above-Mentioned Product Conforms To BP2015/USP38/FCC9/E300/EP8.5 |
CERTIFICATE OF ANALYSIS | ||||
Analysis Contents | Analysis Standard | Analysis Results | ||
Characteristics | White or almost White | Pass | ||
Identification | Positive Reaction | Positive | ||
Melting Point | About 190℃ | 190.2℃ | ||
PH | 2.1-2.6 | 2.41 | ||
Clarity Of Solution | Clear | Clear | ||
Colour Of Solution | ≤BY7 | <BY7 | ||
Copper | ≤5ppm | <5ppm | ||
Heavy Metals | ≤10ppm | <10ppm | ||
Mercury | ≤1ppm | <1ppm | ||
Lead | ≤2ppm | <2ppm | ||
Arsenic | ≤3ppm | <3ppm | ||
Oxalic Acid | ≤0.2% | <0.2% | ||
Iron | ≤2ppm | <2ppm | ||
Loss of Drying | ≤0.4% | <0.04% | ||
Sulphate Ash(Residue On Ignition) | ≤0.1% | <0.04% | ||
Specific Optical Rotation | +20.5°–+21.5° | +21.21° | ||
Impurity E | ≤0.2% | 0.12% | ||
mesh | 40-80mesh | pass | ||
Related Substances | Impurity C;D | ≤0.15% | 0.11% | |
Unspecified Impurities | 0.1% max | 0.05% | ||
Total | 0.2% max | 0.11% | ||
Disregard limit | 0.05% max | 0.05% | ||
Organic Volatile Impurities | Pass | Pass | ||
Assay(Purity) | 99.0%-100.5% | 99.80% | ||
Conclusion | The Above-Mentioned Product Conforms To BP2015/USP38/FCC9/E300/EP8.5 |