Verasitas Labs
SUBSTANCE TESTING REPORT
VALSARTÁN 80MG Quality Assessment
1. Introduction
Comprehensive quality control evaluation of Valsartan including identity confirmation, assay determination and impurity limit testing.
2. Methodology
HPLC,Espectrofotometría UV-Vis
3. Results
| Parameter | Value |
|---|---|
| Sample Identification | VALSARTÁN 80MG (Lote# VAL-319-2024) |
| Concentration | 1.64 mg/mL ± 0.10 |
| Purity | 98.7% |
| Impurities | <1.3% |
4. Discussion
HPLC analysis shows well-resolved peak with excellent symmetry. UV spectroscopy confirms proper compound identity. The impurity profile shows expected related substances within acceptable limits, with special attention to NDMA impurity.
5. Conclusion
VALSARTÁN 80MG demonstrates satisfactory quality with all parameters within established specifications.
Dr. Lisa Müller
Clinical Laboratory Head
17-06-2024