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.
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.
| 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% |
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.