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Spiramycin
| ITEMS | LIMIT |
| Appearance | A white or slightly yellowish powder |
| Identification | |
| A. UV Spectrum | The specific absorbance at the maximum (232nm) |
| is about 340. | |
| B. TLC | Corresponds to reference solution. |
| C. Color Reaction | Brown colour |
| pH | 8.5-10.5 |
| Specific optical rotation | -80°- -85°(dried substance) |
| Composition (HPLC) | |
| SpiramycinⅠ | ≥80.0 % |
| SpiramycinⅡ | ≤5.0 % |
| SpiramycinⅢ | ≤10.0 % |
| Total Spiramycins | ≥90.0 % |
| Related substances (HPLC) | |
| Impurity A (neospiramycin I) | ≤2.0 % |
| Impurity B (spiramycin IV) | ≤2.0 % |
| Impurity C (17-methylenespiramycin I) | ≤2.0 % |
| Impurity E (DSPM) | ≤2.0 % |
| Impurity G (neospiramycin II) | ≤2.0 % |
| Impurity H (neospiramycin III) | ≤2.0 % |
| Impurity D (spiramycin V) | ≤2.0 % |
| Impurity F (spiramycin dimer) | ≤2.0 % |
| Any other impurity | ≤2.0 % |
| Total impurities | ≤10.0 % |
| Heavy metals | ≤20ppm |
| Loss on drying | ≤3.5 % |
| Sulphated ash | ≤0.1 % |
| Assays (wet substance) | No limits (IU/mg) |
| Assays (dried substance) | ≥4100 IU/mg |
| Residual solvents | |
| Dichloromethane | ≤100 ppm |
| Methylisobutylketone | ≤ 1000 ppm |
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