Verasitas Labs
SUBSTANCE TESTING REPORT
Potency and Impurity Profiling of Halo-med Tablets
1. Introduction

This analytical study was conducted to assess the quality of Halo-med tablets, containing Fluoxymesterone. The focus was on accurately determining the potency of the active steroid and creating a comprehensive impurity profile to identify and quantify any degradation products or process-related impurities. This is essential for ensuring the product's therapeutic efficacy and patient safety over its shelf life.

2. Methodology

ELISA and UV-Vis: Enzyme-Linked Immunosorbent Assay (ELISA) provided a highly specific and sensitive measurement of Fluoxymesterone concentration, cross-verifying the results from chromatographic methods. UV-Vis Spectrophotometry was used for a rapid assessment of sample homogeneity and to screen for any unexpected chromophores.

3. Results
Parameter Value
Sample Identification Halo-Med (Lot# C5E8A3B1D-2024)
Dosagen 10mg/tab
Manufacturer: Bioniche
Concentration 7.64 mg/tab
Purity 76.4
Impurities < 23.6%
4. Discussion

5. Conclusion

The evaluation of Halo-med tablets indicates a potency of 7.64 mg/tab, which is below the labeled 10 mg/tab. The purity was found to be 76.4%, and the impurity profile revealed several unidentified peaks requiring further investigation. The product currently does not meet the full specification for potency, and the elevated impurity levels necessitate a review of the manufacturing and raw material sourcing processes.

Firma del doctor
Dr. Robert Johnson
Physicochemical Methods Specialist
11-05-2024