Cartalax Pen certificate of analysis, lot PL-2610-039
Certificate PL-26-00161 reports the release tests for Cartalax Pen lot PL-2610-039: 99.54% purity by reverse-phase HPLC and identity confirmed by LC-MS, tested October 2, 2026. The lot number printed on each unit matches this certificate.
| Certificate number | PL-26-00161 |
|---|---|
| Lot number | PL-2610-039 |
| Compound | Cartalax Pen 20 mg |
| Sequence | H-AED-OH (3 residues; free N- and C-termini) |
| Molecular formula | C12H19N3O8 |
| CAS number | 85806-95-7 |
| Purity (RP-HPLC) | 99.54% |
| Identity (LC-MS) | Conforms (333.28 Da) · expected 333.3 Da, found 333.28 Da |
| Method | RP-HPLC (UV 214 nm) + LC-MS |
| Tested | October 2, 2026 |
| Retest by | October 1, 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 | 333.28 Da (PASS) |
| Purity | RP-HPLC, UV 214 nm, area% | ≥ 99.0% | 99.54% (PASS) |
| Largest impurity | RP-HPLC, area% | ≤ 1.0% | 0.21% (RT 11.40) (PASS) |
| Assay (label claim) | Assay vs label claim | 19–21 mg/mL | 20.29 mg/mL (PASS) |
| Bacterial endotoxin | LAL, kinetic | ≤ 5.0 EU/mg | 0.289 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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