Batch Verification Report
Batch verification and analytical summary for PT-141.
Manufacturer catalog: A005
Manufacture date: 2026-03-27
Recommended retest date: 2028-03-26
Amount: As specified on Celvaris product label
Analytical Results
The following analytical data was obtained from manufacturer testing of batch P260316-A005. Celvaris has independently verified this data against our quality specifications.
| Test | Method | Specification | Result | Status |
|---|---|---|---|---|
| Appearance | Visual | White powder | Conforms | PASS |
| Solubility (water) | Visual | ≥ 5 mg/mL | Conforms | PASS |
| Identity | MS (ESI) | 1025.16 ± 1.0 | 1024.86 | PASS |
| Purity | HPLC | ≥ 98.0% | 99.36% | PASS |
| Related substance | HPLC | Any impurity ≤ 1.0% | 0.37% | PASS |
| Peptide content | N% | ≥ 80.0% | 88.93% | PASS |
| Water content | Karl Fischer | ≤ 10.0% | 2.52% | PASS |
| Acetate content | HPLC | < 12.0% | 6.85% | REPORT |
| TFA content | HPLC | ≤ 0.5% | N.D. | PASS |
| Residual solvents | GC | Below ICH limits | N.D. | PASS |
| Bacterial endotoxins | LAL | < 10 EU/mg | Conforms | PASS |
| Microbial limits | USP | Within limits | Conforms | PASS |
| Assay | HPLC | 95.0–105.0% | 99.24% | PASS |
All parameters above were tested on the manufacturer’s certificate of analysis for this batch.
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 PPE (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. Celvaris does not provide reconstitution instructions.
Additional Documentation:
For questions about this batch or to request additional information, contact [email protected]
All tested parameters conform to specification. No deviations noted.