| Certification: | GMP, FDA |
|---|---|
| Grade Standard: | Medicine Grade |
| Type: | Pharmaceutical |
| State: | Solid |
| Volatile: | Not Volatile |
| CAS Registry Number: | 130018-87-0 |
| Customization: |
|---|
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Beijing Mesochem Technology Co., Ltd is located in national economic and technological development of Yizhuang, which is a gathering place of world's top 500 enterprises. Devoting to pharmaceutical chemicals, find chemicals, and fundamental chemical material, Mesochem owns independent right of import and export.Based on abundant resources from Beijing various colleges and universities, Mesochem focused on incessant innovation along with research and development of new products. | 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 | ||
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