certificate of analysis, lot PL-2609-050
Certificate PL-26-00050 reports the release tests for lot PL-2609-050: 98.60% purity by reverse-phase HPLC and identity confirmed by LC-MS, tested September 19, 2026. The lot number printed on each unit matches this certificate.
| Certificate number | PL-26-00050 |
|---|---|
| Lot number | PL-2609-050 |
| Compound | null |
| Purity (RP-HPLC) | 98.60% |
| Identity (LC-MS) | Conforms (2 / 2) |
| Method | RP-HPLC (UV 214 nm) + LC-MS |
| Tested | September 19, 2026 |
| Retest by | September 18, 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 |
|---|---|---|---|
| Appearance | Visual inspection | White to off-white lyophilized powder or cake | White lyophilized cake (PASS) |
| Identity | LC-MS, ESI positive | FSH/LH within glycoform envelopes | FSH 30,084 Da · LH 28,577 Da centroids (PASS) |
| Purity | RP-HPLC, UV 214 nm, area% | ≥ 95.0% (98.6%) | |
| Largest impurity | RP-HPLC, area% | ≤ 5.0% | 0.8% at 7.82 min (PASS) |
| Water content | Karl Fischer | 5.0% | 1.8% (PASS) |
| Bacterial endotoxin | LAL, kinetic | ≤ 5.0 EU/mg | 0.23 EU/mg (PASS) |
| Sterility / bioburden | USP <71>, membrane filtration | No growth after 14 days | No growth; conforms (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 lots
- PL-26-00120, lot PL-2609-120, 99.54%, tested September 19, 2026
- PL-26-00104, lot PL-2609-104, 99.53%, tested September 19, 2026
- PL-26-00079, lot PL-2609-079, 99.56%, tested September 19, 2026
- PL-26-00047, lot PL-2609-047, 99.24%, tested September 19, 2026
- PL-26-00046, lot PL-2609-046, 99.20%, tested September 19, 2026
- PL-26-00031, lot PL-2609-031, 99.18%, tested September 19, 2026
- PL-26-00026, lot PL-2609-026, 99.51%, tested September 19, 2026
- PL-26-00020, lot PL-2609-020, 99.70%, tested September 19, 2026
For laboratory research use only. Not for human or veterinary consumption. Products have not been evaluated by the U.S. Food and Drug Administration and are not intended to diagnose, treat, cure or prevent any disease.