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 |
Loss on Drying | ≤ 0.50% | 0.32% |
Heavy Metal | ≤ 10ppm | Complies |
Residue on Ignition | ≤ 0.20% | 0.05% |
Enantiomer | (SS) ≤0.1% | ND |
Citrate | 36.2% ~ 40.0% (on dried basis) | 37.3% |
Residual Solvents | : ≤3000ppm | ND |
Ethanol: ≤5000ppm | 260ppm | |
: ≤5000ppm | ND | |
: ≤5000ppm | ND | |
n-Butyl alcohol: ≤5000ppm | ND | |
: ≤600ppm | ND | |
Related Substances | (RS+SR): ≤0.10% | ND |
Any single impurity: ≤0.10% | 0.07% | |
Total Impurities: ≤0.30% | 0.21% | |
Assay (HPLC basis on drying) |
99.0%~101.0% | 99.85% |
Particle Size | D90: ≤50µm | 27.61µm |
Reference Standard | In-house Standard | |
Conclusion | The product complied with In-house standards. | |
Storage | Preserve in tight,light-resistant containers in a cool place |