| Function: | Immunosuppressant |
|---|---|
| Certification: | GMP |
| Grade Standard: | Medicine Grade |
| Type: | Chemical Reagent |
| State: | Powder |
| Volatile: | Not Volatile |
| Samples: |
|---|
Suppliers with verified business licenses
Audited Supplier | Items | Standard | Results |
| Appearance | White or almost white,crystalline powder;odorless | Almost white crystalline powder;odorless |
| Solubility | Freely soluble in acetone,sparingly soluble in anhydrous ethanol,practically insoluble in water | / |
| Melting point | About 96ºC | 95.5~96.5ºC |
| Identification | ||
| IR | Conform to the CRS | Conform |
| Appearance of solution | The solution is clear and colorless | Conform |
| Loss on drying | Not more than 0.5% | Less than 0.1% |
| Sulfated ash | Not more than 0.1% | Less than 0.1% |
| Related substances | ||
| Impurity F | Not more than 0.5% | 0.03% |
| Impurity B | Not more than 0.2% | Not detected |
| Impurity A | Not more than 0.1% | Not detected |
| Impurity D | Not more than 0.1% | Not detected |
| Impurity E | Not more than 0.1% | Not detected |
| Impurity G | Not more than 0.1% | Not detected |
| Impurity H | Not more than 0.1% | Not detected |
| Any other impurity | Not more than 0.1% | Not detected |
| Total impurities | Not more than 0.7% | Less than 0.1% |
| Residual solvents | ||
| Toluene | Not more than 0.089% | 0.001% |
| Dimethybenzene | Not more than 0.03% | Not detected |
| Isopropanol | Not more than 0.5% | Less than 0.1% |
| Microbial limit | TAMC:Not more than103 CFU/g | Less than 10 CFU/g |
| TYMC:Not more than 102 CFU/g | Less than 10 CFU/g | |
| Escherichia coli:Not detected | Not detected | |
| Assay (dried substance) | 98.0%~102.0% | 100.6% |
Suppliers with verified business licenses
Audited Supplier 
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