Batch Verification Report
Batch verification and analytical summary for Cagrilintide (long-acting amylin analogue research peptide).
Filler-free lyophilised peptide powder · No mannitol or bulking agents
Manufacture date: 22 Dec 2025
Recommended retest date: 21 Dec 2027
Amount: As specified on Aventris product label
Analytical Results
The following analytical data was obtained from manufacturer testing of the source batch. Aventris has independently verified this data against our quality specifications. This Batch Verification Report summarises our review findings for Cagrilintide.
| Test | Method | Specification | Result |
|---|---|---|---|
| Appearance | Visual | White powder | Conforms |
| Solubility (water) | Solubility check | Soluble in water | Conforms |
| Identity (molecular weight) | ESI-MS | 4409.10 ± 1.0 Da | 4409.00 Da |
| Purity | HPLC | ≥ 99.0% | 99.13% |
| Related substances – Total | HPLC | ≤ 1.0% | 0.87% |
| Related substances – Any individual | HPLC | ≤ 0.5% | 0.39% |
| Peptide content | Nitrogen analysis (N%) | ≥ 85.0% | 95.49% |
| Water content | Karl Fischer | ≤ 10.0% | 2.96% |
| High molecular protein | SEC | ≤ 0.5% | Not detected |
| Acetate content | HPLC | ≤ 12.0% | 4.62% |
| TFA content | HPLC | ≤ 0.25% | Not detected |
| Assay (HPLC) | HPLC | 95.0 – 105.0% (anhydrous, salt-free basis) | 103.14% |
| Residual solvents – Acetonitrile | GC | NMT 410 ppm | Not detected |
| Residual solvents – Methanol | GC | NMT 3000 ppm | Not detected |
| Residual solvents – Methylene chloride | GC | NMT 600 ppm | Not detected |
| Residual solvents – N,N-Dimethylformamide | GC | NMT 880 ppm | Not detected |
| Residual solvents – Isopropyl ether | GC | NMT 5000 ppm | Not detected |
| Bacterial endotoxins | Pharmacopeial method | < 10 EU/mg | Conforms |
| Total aerobic microbial count | Plate count | ≤ 1000 cfu/g | Conforms |
| Total yeast & mold count | Plate count | ≤ 200 cfu/g | Conforms |
| Amino Acid | Specification | Result |
|---|---|---|
| His | 0.8 – 1.2 | 0.88 |
| Asp | 4.0 – 6.0 | 4.14 |
| Arg | 1.6 – 2.4 | 2.38 |
| Lys | 0.8 – 1.2 | 0.95 |
| Ile | 0.8 – 1.2 | 1.08 |
| Leu | 2.4 – 3.6 | 3.21 |
| Val | 0.8 – 1.2 | 1.08 |
| Thr | 4.0 – 6.0 | 4.71 |
| Phe | 1.6 – 2.4 | 2.39 |
| Ser | 2.4 – 3.6 | 3.02 |
| Ala | 2.4 – 3.6 | 2.82 |
| Gly | 1.6 – 2.4 | 2.19 |
| Glu | 2.4 – 3.6 | 2.95 |
| Pro | 3.2 – 4.8 | 4.18 |
Storage & Handling
Storage Conditions:
- Store at -20°C or below in original sealed vial
- Protect from light and moisture
- Do not freeze-thaw repeatedly once reconstituted
- Recommended shelf life: 24 months when stored properly
General Laboratory Handling:
- Handle using standard laboratory safety practices
- Wear appropriate personal protective equipment (gloves, lab coat, safety glasses)
- Use in well-ventilated area or fume hood
- Avoid inhalation, ingestion, or skin/eye contact
- Wash hands thoroughly after handling
Reconstitution:
Reconstitution methods, diluents, and working concentrations must be determined by qualified researchers
according to their specific experimental protocols and institutional guidelines. Aventris does not provide
reconstitution instructions.
Source Batch:
- Cagrilintide — Lot P251210-F064
Peptide Sequence:
Cagrilintide (39 AA):
Eicosanedioic acid-γ-EKCNTATCATQRLAEFLRHSSNNFGPILPPTNVGSNTP-NH₂
(Disulfide bridge: Cys3–Cys8)
Molecular Identity:
- Cagrilintide: C₁₉₄H₃₁₂N₅₄O₅₉S₂ — MW 4409.10 Da — CAS 1415456-99-3
Additional Documentation:
For questions about this batch or to request additional information, contact
[email protected]
Note: Any deviations from the above specification, if present, will be explicitly noted. In the absence of such notes, all parameters conform to the stated limits.