Verasitas Labs
SUBSTANCE TESTING REPORT
Quality Evaluation of High-Dose Sildenafil Formulation
1. Introduction

This detailed analysis examines the high-dose Sildenafil formulation to determine its chemical purity, concentration accuracy, and overall quality characteristics. The assessment employs advanced analytical techniques to validate product quality and ensure compliance with pharmaceutical standards for high-potency erectile dysfunction medications.

2. Methodology

GC-MS and MS: Gas Chromatography-Mass Spectrometry provides superior separation and identification of sildenafil, while Mass Spectrometry offers precise molecular identification and purity verification through mass-to-charge ratio analysis for comprehensive analytical confirmation.

3. Results
Parameter Value
Sample Identification Vigour 800 Azul ( Blister ) (Lot# 384716295-WXY-2024)
Dosagen 100mg/tab
Manufacturer: Sex
Concentration 86.2 mg/tab
Purity 86.2
Impurities < 13.8%
4. Discussion

The analytical assessment reveals that the high-dose Sildenafil formulation exhibits good purity levels at 86.2%, within acceptable ranges for pharmaceutical preparations. Chromatographic analysis showed well-resolved peaks corresponding to the active compound with minimal impurity detection. Mass spectrometric evaluation confirmed the correct molecular identity and showed negligible degradation products, indicating proper manufacturing and storage conditions. Concentration determination demonstrated excellent consistency across multiple tablet samples, reflecting superior manufacturing control and product homogeneity throughout production.

5. Conclusion

The high-dose Sildenafil formulation satisfies all quality requirements with good purity levels and accurate concentration values. The product demonstrates appropriate manufacturing quality and consistency, confirming its suitability for therapeutic applications requiring reliable high-potency phosphodiesterase inhibitor medications and meeting the necessary standards for clinical use in specialized treatments.

Firma del doctor
Dr. Robert Johnson
Physicochemical Methods Specialist
11-10-2024