| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
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| Batch No. | HF171215 | Quantity | 1250kgs |
| Mfg. Date | Dec. 15, 2017 | Package | As required |
| Rep. Date | Dec. 18, 2017 | Exp. Date | Dec. 14, 2020 |
| Items | Standards | Results | |
| Appearance | Yellow crystalline powder | Complies | |
| Identification | A) TR of HPLC test | Complies | |
| B) Sulphuric acid yellow color reaction | Complies | ||
| C) Chloride's reaction | Complies | ||
| Specific Optical Rotation | -105°~-120°, calculated on the anhydrous, ethanol-free substances |
-112° | |
| Specific Absorbance | 300~335 at 349nm, calculated on the anhydrous, ethanol-free substances |
319 | |
| Light-absorbing Impurities | No more than 0.07 at 490nm calculated on the anhydrous, ethanol-free substances |
0.02 | |
| Water | 1.4%~2.8% | 2.1% | |
| Sulfated Ash | ≤ 0.40% | <0.1 | |
| Heavy Metals | ≤ 50ppm | < 50ppm | |
| Residual Solvents | Ethanol: 4.3%~6.0% | 4.6% | |
| Related Substances | Metacycline: ≤2.00% | 0.06% | |
| 6-Epidoxycycline: ≤2.00% | 1.86% | ||
| Oxytetracycline: ≤0.50% | 0.02% | ||
| 4-Epidoxycycline: ≤0.50% | 0.01% | ||
| 4,6-Epidoxycycline: ≤0.50% | ND | ||
| Impurity F: ≤0.50% | 0.37% | ||
| Any other impurities: ≤0.10% | 0.01% | ||
| Assay(%) | 95.0%~102.0% of C22H25ClN2O8, calculated on the anhydrous, ethanol-free substance |
98.2% | |
| Reference Standard | BP2017 Standard | ||
| Conclusion | The product complied to BP2017 standard. | ||
| Storage | Preserve in tight,light-resistant containers in a cool place |
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