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Quality Standard of rhKGF
Test items |
Standard |
| Purity (%) min | 95 |
| Biological Activity unit (IU/mg) Min | 1*105 |
| Identification test | It is white and aerosols. |
| Appearance | Freeze-dried powder. Added into 1ml distilled water, it can solve quickly. It should not contain insoluble matter seen by naked eyes |
| pH value | 6.8~7.2 |
| Water residue (%) max | 3.0 |
| Sterility test | No bacterial growth |
| Abnormal toxicity exp. | The tested animals have No abnormal reactions. They keep healthy, and have weight increase. |
