| 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 | |||