Tirzepatide certificate of analysis, lot PL-2610-224
Certificate PL-26-00337 reports the release tests for Tirzepatide lot PL-2610-224: 99.15% purity by reverse-phase HPLC and identity confirmed by LC-MS, tested October 8, 2026. The lot number printed on each unit matches this certificate.
| Certificate number | PL-26-00337 |
|---|---|
| Lot number | PL-2610-224 |
| Compound | Tirzepatide 100 mg |
| Sequence | H-Y-Aib-EGTFTSDYSI-Aib-LDKIAQK(2×AEEA-γGlu-C20 diacid)AFVQWLIAGGPSSGAPPPS-NH₂ (39 residues; Aib2 and Aib13; Lys20 acylated with eicosanedioic acid via γ-Glu and two AEEA spacers; C-terminal amide) |
| Molecular formula | C225H348N48O68 |
| CAS number | 2023788-19-2 |
| Purity (RP-HPLC) | 99.15% |
| Identity (LC-MS) | Conforms (4,813.17 Da) · expected 4813.45 Da, found 4813.17 Da |
| Method | RP-HPLC (UV 214 nm) + LC-MS |
| Tested | October 8, 2026 |
| Retest by | October 7, 2028 |
| Tested by | Manufacturer’s in-house laboratory (not an independent third-party test) |
| Conclusion | Conforms |
Tests run on this lot
| Test | Method | Specification | Result |
|---|---|---|---|
| Identity (mass) | LC-MS, ESI positive | Theoretical ± 1.0 Da | 4,813.17 Da (PASS) |
| Purity | RP-HPLC, UV 214 nm, area% | ≥ 99.0% | 99.15% (PASS) |
| Largest impurity | RP-HPLC, area% | ≤ 1.0% | 0.34% (RT 13.20) (PASS) |
| Water content | Karl Fischer | ≤ 5.0% | 2.83% (PASS) |
| Bacterial endotoxin | LAL, kinetic | ≤ 5.0 EU/mg | 0.392 EU/mg (PASS) |
| Sterility | USP <71>, 14-day | No growth | No growth (PASS) |
What these results mean
HPLC purity is the share of UV-detectable material that elutes as the target compound; it is not the same as net peptide content, which also accounts for water and counter-ions. Identity means the measured mass matched the mass calculated for the compound. A certificate reports only the tests run on this lot; endotoxin, sterility and contaminant panels are not part of standard lot release. How to read a certificate of analysis.
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Other Tirzepatide lots
- PL-26-00336, lot PL-2610-223, 99.34%, tested October 8, 2026
- PL-26-00335, lot PL-2610-222, 99.25%, tested October 8, 2026
- PL-26-00334, lot PL-2610-221, 99.28%, tested October 8, 2026
- PL-26-00333, lot PL-2610-220, 99.37%, tested October 8, 2026
- PL-26-00332, lot PL-2610-219, 99.22%, tested October 8, 2026
- PL-26-00331, lot PL-2610-218, 99.33%, tested October 8, 2026
- PL-26-00330, lot PL-2610-217, 99.25%, tested October 8, 2026
- PL-26-00329, lot PL-2610-216, 99.30%, tested October 8, 2026
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