| Product | Erythromycin Base | |
| Shelf Life | 3 years | |
| Test Items | Specification | Results |
| Characteristics | White,crystalline powder | White,crystalline powder |
| Identification | To comply | Complies |
| TESTS | ||
| Specific optical rotation | -71°一78° | -74° |
| Related substances | To comply | Complies |
| Any impurity | <3.0% | 2.7% |
| Total impurity | <7.0% | 5.9% |
| Thiocyanate | <0.3% | Complies |
| Water | <6.5%w/w | 4.3%w/w |
| Sulphated ash | <0.2%w/w | Complies |
| ASSAY (anhydrous substance) | 93.0%~102.0% | 98.2% |
| Erythromycin B | <5.0% | 2.8% |
| Ervthromvcin C | <5.0% | 3.3% |
| Conclusion: Product complies with EP6.0. | ||