Lot / batch number
PL-2610-112
| Test | Method | Specification | Result | Conclusion |
|---|---|---|---|---|
| GHK-Cu: purity · largest impurity · mass | RP-HPLC 214 nm (area%); LC-MS, ESI+ | ≥ 99.0% · ≤ 1.0% · ± 1.0 Da | 99.67% · 0.26% · 401.90 Da | PASS |
| BPC-157: purity · largest impurity · mass | RP-HPLC 214 nm (area%); LC-MS, ESI+ | ≥ 99.0% · ≤ 1.0% · ± 1.0 Da | 99.37% · 0.28% · 1,419.53 Da | PASS |
| TB-500: purity · largest impurity · mass | RP-HPLC 214 nm (area%); LC-MS, ESI+ | ≥ 99.0% · ≤ 1.0% · ± 1.0 Da | 99.58% · 0.21% · 4,963.43 Da | PASS |
| KPV: purity · largest impurity · mass | RP-HPLC 214 nm (area%); LC-MS, ESI+ | ≥ 99.0% · ≤ 1.0% · ± 1.0 Da | 99.82% · 0.09% · 342.42 Da | PASS |
| Water content | Karl Fischer | ≤ 5.0% | 2.79% | PASS |
| Bacterial endotoxin | LAL, kinetic | ≤ 5.0 EU/mg | 0.469 EU/mg | PASS |
| Sterility | USP <71>, 14-day | No growth | No growth | PASS |
| Time (min) | % A | % B |
|---|---|---|
| 0.0 | 95 | 5 |
| 25.0 | 5 | 95 |
| Peak | RT (min) | Area | Area % |
|---|---|---|---|
| 1 | 4.70 † | — | 0.06 |
| 2 | 5.68 | — | 99.82 |
| 3 | 6.50 † | — | 0.09 |
| 4 | 7.10 † | — | 0.03 |
| 5 | 9.30 † | — | 0.02 |
| 6 | 10.70 | — | 99.67 |
| 7 | 11.40 † | — | 0.21 |
| 8 | 11.50 † | — | 0.05 |
| 9 | 12.20 † | — | 0.26 |
| 10 | 12.20 † | — | 0.28 |
| 11 | 13.03 | — | 99.37 |
| 12 | 13.20 † | — | 0.21 |
| 13 | 13.90 † | — | 0.14 |
| 14 | 13.90 † | — | 0.17 |
| 15 | 14.77 | — | 99.58 |
| 16 | 15.60 † | — | 0.04 |
| Test | Performed by | Date | Report / file |
|---|---|---|---|
| Water content (Karl Fischer) | PrymaLab Analytical | 2026-10-06 | — |
| Endotoxin (LAL, kinetic) | PrymaLab Analytical | 2026-10-06 | — |
| Sterility (USP <71>, day-14 read-out) | PrymaLab Analytical | 2026-10-20 | — |