Batch Verification Report
Batch verification and analytical summary for TB-500 Fragment.
Manufacture date: 05 Jan 2026
Recommended retest date: 04 Jan 2028
Amount: As specified on Celvaris product label
Analytical Results
The following analytical data was obtained from manufacturer testing of batch P251226-A033. Celvaris has independently verified this data against our quality specifications. This Batch Verification Report summarises our review findings.
| Test | Method | Specification | Result |
|---|---|---|---|
| Appearance | Visual | White powder | Conforms |
| Solubility (water) | Visual / solubility check | Soluble in water | Conforms |
| Identity | MS (ESI) | Conforms to structure | Conforms |
| Purity | HPLC | ≥ 99.0% | 99.70% |
| Peptide content | Peptide content | ≥ 80.0% | 89.54% |
| Water content | Karl Fischer | ≤ 10.0% | 2.15% |
| Acetate content | HPLC | < 12.0% | 2.96% |
| TFA content | HPLC | ≤ 0.5% | Not detected |
| Residual solvents – Acetonitrile | GC | NMT 410 ppm | Not detected |
| Residual solvents – Ethyl ether | GC | NMT 5000 ppm | Not detected |
| Residual solvents – Dichloromethane | GC | NMT 600 ppm | Not detected |
| Residual solvents – Pyridine | GC | NMT 200 ppm | Not detected |
| Residual solvents – N,N-Dimethylformamide | GC | NMT 880 ppm | Not detected |
| Residual solvents – Triisopropylsilane | GC | NMT 1000 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 |
| Assay (HPLC) | HPLC | 95.0 – 105.0% (anhydrous, salt-free basis) | 102.51% |
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. Celvaris does not provide
reconstitution instructions.
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.