Customization: | Available |
---|---|
Powder: | Yes |
Customized: | Customized |
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Audited by an independent third-party inspection agency
Items | Standards | Results | |
Appearance | White or off-white solid powder | White solid powder | |
Identification | By IR | Complies | |
By HPLC | Complies | ||
Specific Rotation | +24.0°~+28.0°(DMF:MeOH=1:1 c=1%) | +9.5° | |
pH | 5.5~7.5 | 6.8 | |
Water Content | 5.6%~7.2% | 6.1% | |
Heavy Metal | ≤ 20ppm | Complies | |
Residue on Ignition | ≤ 0.10% | 0.04% | |
Enantiomer | ≤ 0.20% | ND | |
Residual Solvents | M'ethanol: ≤3000ppm | ND | |
D'ichloromethane: ≤600ppm | ND | ||
T'etrahydrofuran: ≤720ppm | ND | ||
T'oluene: ≤890ppm | ND | ||
H'exane: ≤290ppm | ND | ||
DMF: ≤880ppm | ND | ||
Related Substances | Any single impurity: ≤0.10% | 0.05% | |
Total Impurities: ≤0.30% | 0.07% | ||
Assay (HPLC basis on drying) |
98.0%~102.0% | 99.90% | |
Reference Standard | In-house Standard | ||
Conclusion | The product complied to In-house standard. | ||
Storage | Preserve in tight,light-resistant containers in a cool place |