Ovagen Nasal Spray certificate of analysis, lot PL-2610-139
Certificate PL-26-00253 reports the release tests for Ovagen Nasal Spray lot PL-2610-139: 99.76% purity by reverse-phase HPLC and identity confirmed by LC-MS, tested October 7, 2026. The lot number printed on each unit matches this certificate.
| Certificate number | PL-26-00253 |
|---|---|
| Lot number | PL-2610-139 |
| Compound | Ovagen Nasal Spray 20 mg |
| Sequence | H-EDL-OH (3 residues; free N- and C-termini) |
| Molecular formula | C15H25N3O8 |
| CAS number | Not assigned |
| Purity (RP-HPLC) | 99.76% |
| Identity (LC-MS) | Conforms (375.43 Da) · expected 375.4 Da, found 375.43 Da |
| Method | RP-HPLC (UV 214 nm) + LC-MS |
| Tested | October 7, 2026 |
| Retest by | October 6, 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 | 375.43 Da (PASS) |
| Purity | RP-HPLC, UV 214 nm, area% | ≥ 99.0% | 99.76% (PASS) |
| Largest impurity | RP-HPLC, area% | ≤ 1.0% | 0.19% (RT 12.60) (PASS) |
| Assay (label claim) | Assay vs label claim | 19–21 mg/bottle | 19.64 mg/bottle (PASS) |
| Bacterial endotoxin | LAL, kinetic | ≤ 5.0 EU/mg | 0.466 EU/mg (PASS) |
| Aerobic count (TAMC) | USP <61> | < 10 CFU/mL | < 10 CFU/mL (PASS) |
| Yeast & mold (TYMC) | USP <61> | < 10 CFU/mL | < 10 CFU/mL (PASS) |
| E. coli | USP <62> | Absent | Absent (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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