Batch Verification Report
Batch verification and analytical summary for Larazotide.
Manufacturer catalog: L009
Manufacture date: 2024-12-10
Recommended retest date: 2026-12-09
Amount: As specified on Celvaris product label
Analytical Results
The following analytical data was obtained from manufacturer testing of batch P241120-L009. Celvaris has independently verified this data against our quality specifications.
| Test | Method | Specification | Result | Status |
|---|---|---|---|---|
| Appearance | Visual | White to off-white powder | Conforms | PASS |
| Identity | MS (ESI) | Consistent with structure | Conforms | PASS |
| Purity | HPLC | ≥ 98.0% | 99.58% | PASS |
| Peptide content | N% | ≥ 80.0% | 87.02% | PASS |
| Acetate content | HPLC | < 12.0% | 6.16% | REPORT |
| Water content | Karl Fischer | ≤ 10.0% | 3.05% | PASS |
| Mass balance | HPLC | 95.0–105.0% | 96.23% | PASS |
Parameters not listed above were not included on the manufacturer’s certificate of analysis for this batch and are therefore not reported here.
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.