| Customization: | Available |
|---|---|
| Certification: | GMP, FDA, ISO |
| Grade Standard: | Medicine Grade |
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| 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 | |
| pH | 2.0~3.0 | 2.5 |
| Specific Optical Rotation | -105°~-120°, calculated on the anhydrous, ethanol-free substances |
-110° |
| Specific Absorbance | 300~335 at 349nm, calculated on the anhydrous, ethanol-free substances |
320 |
| Light-absorbing Impurities | No more than 0.07 at 490nm calculated on the anhydrous, ethanol-free substances |
0.02 |
| Water | 1.4%~2.8% | 1.8% |
| Sulfated Ash | ≤ 0.40% | <0.1 |
| Heavy Metals | ≤ 50ppm | < 50ppm |
| Residual Solvents | Ethanol: 4.3%~6.0% | 4.6% |
| Related Substances | Metacycline: ≤2.00% | 0.12% |
| 6-Epidoxycycline: ≤2.00% | 1.56% | |
| Oxytetracycline: ≤0.50% | 0.06% | |
| 4-Epidoxycycline: ≤0.50% | 0.02% | |
| 4,6-Epidoxycycline: ≤0.50% | ND | |
| Impurity F: ≤0.50% | 0.34% | |
| Any other impurities: ≤0.50% | 0.01% | |
| Assay(%) | 95.0%~102.0% of C22H25ClN2O8, calculated on the anhydrous, ethanol-free substance |
98.6% |
| 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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