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Method validation for Boehringer Ingelheim Metalyse release tests.
| Test method | Intermediate precision coefficient of variation (%) |
|---|---|
| Clot lysis activity assay | 2 |
| Chain composition by HP-SEC | 1 |
| Purity (monomer) by HP-SEC | 1 |
| Host cell proteins by CHOP ELISA | 24 |
| Type I/II by RP-HPLC | 1 |
