| Customization: | Available |
|---|---|
| Function: | Antibiotic and Antimicrobial Agents |
| Certification: | GMP |
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| Items | Criteria | Results |
| Characteristics | A white or almost white powder, freely soluble in water, practically insoluble in alcohol and in ether | Complies |
| Identification | Tests according to monograph | Complies |
| Appearance of solution | Clear and not more intensely colored than degree 6 of the range of reference solutions of the most appropriate color | Complies |
| pH | 3.5 ~5.5 | 4.6 |
| Specific optical rotation | +107°~+121° | +117° |
| Methanol | Not more than 1.0% | Complies |
| Composition | C1: 25%~50% C1a: 10%~35% C2a: 25%~55% |
27.3% 29.1% 43.6% |
| Water | Not more than 15.0% | 9.0% |
| Sulphated ash | Not more than 1.0% | 0.1% |
| Sulphate | 32.0%~35.0% | 34.0% |
| sterility | Complies with the test for sterility | Complies |
| Bacterial endotoxins | Not more than 1.67IU/mg | Complies |
| Assay | Not less than 590IU/mg | |
| (anhydrous substance ) | 659IU/mg | |
| (hydrous substance) | 600IU/mg |
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