5-Amino-1MQ Pen certificate of analysis, lot PL-2610-004
Certificate PL-26-00127 reports the release tests for 5-Amino-1MQ Pen lot PL-2610-004: 99.75% 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-26-00127 |
|---|---|
| Lot number | PL-2610-004 |
| Compound | 5-Amino-1MQ Pen 150 mg |
| Sequence | Quinolinium salt (iodide); the 5-amino-1-methylquinolinium cation is 159.2 Da and is the species observed by ESI-MS. |
| Molecular formula | C10H11IN2 |
| CAS number | 42464-96-0 |
| Purity (RP-HPLC) | 99.75% |
| Identity (LC-MS) | Conforms (159.10 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 | 159.10 Da (PASS) |
| Purity | RP-HPLC, UV 254–306 nm, area% | ≥ 99.0% | 99.75% (PASS) |
| Largest impurity | RP-HPLC, area% | ≤ 1.0% | 0.11% (RT 11.63) (PASS) |
| Assay (label claim) | Assay vs label claim | 47.5–52.5 mg/mL | 50.38 mg/mL (PASS) |
| Bacterial endotoxin | LAL, kinetic | ≤ 5.0 EU/mg | 0.360 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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