Batch Verification Report
Batch verification and analytical summary for Bronchogen.
Manufacturer catalog: M20794
QC release date: 2025-12-01
Amount: As specified on Celvaris product label
Analytical Results
The following analytical data was obtained from manufacturer testing of batch P251111-M20794. 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 | ≥ 99.0% | 99.04% | PASS |
| Salt content | HPLC | ≤ 15.0% | 10.08% | REPORT |
| Water content | Karl Fischer | ≤ 10.0% | 1.30% | PASS |
Parameters not listed above (e.g. residual solvents, bacterial endotoxins, microbial limits) 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.