Customization: | Available |
---|---|
Powder: | Yes |
Customized: | Customized |
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Batch No. | HF170321 | Quantity | 2.2kg |
Mfg. Date | Mar. 21, 2017 | Package | As required |
Rep. Date | Mar. 24, 2017 | Exp. Date | Mar. 20, 2019 |
Items | Standards | Results | |
Appearance | White or off-white solid powder | Conforms | |
Identification | By IR | Conforms | |
By HPLC | Conforms | ||
Solubility | Freely soluble in Water; very sparingly soluble in Ethanol | Conforms | |
pH | 7.0 ~9.0 | 7.80 | |
Loss on Drying | ≤ 1.00% | 0.07% | |
Heavy Metal | ≤ 20ppm | Conforms | |
Residue on Ignition | ≤ 0.10% | 0.05% | |
Residual Solvents | Ethanol: ≤5000 ppm | ND | |
Ethyl acetate:≤5000 ppm | ND | ||
Isopropanol:≤5000 ppm | ND | ||
Relative Substance | Any Single Unknown Impurity: ≤ 0.10% | 0.05% | |
Total Impurities: ≤ 0.50% | 0.11% | ||
Purity(by HPLC) | ≥99.0% | 99.89% | |
Bulk density | ≤ 1.00 | 0.60 | |
Tapped density | ≤ 1.00 | 0.75 | |
Particle Size | D90 ≤180μm | Conforms | |
Bacterial Endotoxin Limit | ≤ 1.1 IU/mg | Conforms | |
Reference Standard | In-house Standard | ||
Conclusion | The product complied to In-house standard. | ||
Storage | Preserve in tight,light-resistant containers in a cool place |