Customization: | Available |
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Certification: | GMP, FDA |
Grade Standard: | Medicine Grade |
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Batch No. | HF170422 | Quantity | 32.5kgs |
Mfg. Date | Apr. 22, 2017 | Package | As required |
Rep. Date | Apr. 27, 2017 | Exp. Date | Apr. 21, 2019 |
Items | Standards | Results | |
Appearance | White to off-white crystalline powder | White solid powder | |
Identification | By IR | Complies | |
By HPLC | Complies | ||
By Chloride: It gives a reaction of Chloride | Positive reaction | ||
Melting Point | 111ºC~116ºC | 112ºC~118ºC | |
Water | ≤0.5% | 0.3% | |
Residue on Ignition | ≤ 0.20% | 0.02% | |
Heavy Metals | ≤ 10ppm | Complies | |
Enantiomer | ≤ 2.00% | 0.24% | |
Residual Solvent | Dichloromethane: ≤600ppm | ND | |
Acetone: ≤5000ppm | ND | ||
Ethyl Acetate: ≤5000ppm | 600ppm | ||
Methanol: ≤3000ppm | ND | ||
Related Substances | Maximum single impurity: ≤0.50% | 0.07% | |
Total impurities: ≤1.00% | 0.09% | ||
Purity(EE) | ≥ 99.0% | 99.91% | |
Assay (HPLC basis on drying) |
98.0%~102.0% | 99.92% | |
Reference Standard | In-house Standard | ||
Conclusion | The product complied to In-house standard. | ||
Storage | Preserve in tight,light-resistant containers in a cool place |