Verasitas Labs
SUBSTANCE TESTING REPORT
Simvastatin 40mg HMG-CoA Reductase Inhibitor Analysis
1. Introduction
Comprehensive quality analysis of Simvastatin 40mg tablets was conducted to assess the potency and stability of this cholesterol-lowering agent. The testing focused on lactone formation potential and degradation products characteristic of statin medications.
2. Methodology
HPLC, UV-Vis
3. Results
| Parameter | Value |
|---|---|
| Sample Identification | SIMVASTATINA 40MG (Lote# SIM40-2024) |
| Concentration | 2.15 mg/mL ± 0.14 |
| Purity | 98.2% |
| Impurities | < 1.8% |
4. Discussion
UV-Vis spectroscopy confirmed the characteristic statin chromophore with appropriate absorbance patterns. HPLC analysis demonstrated excellent purity with minimal lactone formation. Stability testing under accelerated conditions showed robust chemical integrity, with degradation products well within acceptable limits for this sensitive molecule.
5. Conclusion
The product meets all quality specifications for HMG-CoA reductase inhibitors and demonstrates exceptional stability profile.
Dr. Carlos Mendoza
Head of Analytical Quality Control
21-07-2025