| Assay | Method | Acceptance criterion | Result | Pass |
|---|---|---|---|---|
| Purity | SDS-PAGE & RP-HPLC | ≥ 98% | 99.2% | PASS |
| Endotoxin | LAL | ≤ 0.1 EU/µg | 0.046 EU/µg | PASS |
| Bioactivity (ED50) | BALB/c 3T3 fibroblast proliferation | 0.1–0.6 ng/mL | 0.46 ng/mL | PASS |
| Molecular weight | SDS-PAGE | 17.2 kDa ± 10% | 18 kDa | PASS |
Released for sale. All results meet the acceptance criteria published in this product's specification. This Certificate of Analysis applies only to the lot identified above.
Quality Assurance, Bramante Biologics
bramantebio.com/support/coa/BB-GF-260329-N2T2/