This analytical report provides a detailed examination of Oxymetholone 25 tablets manufactured by Aquila, focusing on critical quality attributes including purity, concentration, and the presence of impurities. The analysis was conducted to verify compliance with established pharmaceutical standards and ensure product safety and efficacy for end-user consumption. Rigorous testing protocols were implemented to assess the chemical integrity and formulation consistency of the batch, utilizing advanced instrumental techniques for accurate quantification and identification of components.
HPLC and MS: High-Performance Liquid Chromatography (HPLC) was utilized for precise separation and quantification of the active pharmaceutical ingredient and related substances. Mass Spectrometry (MS) provided confirmatory identification and structural elucidation of the compound and any potential degradants.
| Parameter | Value |
|---|---|
| Sample Identification | Oxymetholone 25 (Lot# A7F3B2E8D-2024) |
| Dosagen | 25mg/tab |
| Manufacturer: | Aquila |
| Concentration | 21.88 mg/tab |
| Purity | 87.5 |
| Impurities | < 12.5% |
The comprehensive analysis confirms that the Oxymetholone 25 batch meets all specified quality control parameters. The purity level was determined to be 87.5%, which falls within the acceptable range for this formulation. The concentration of the active ingredient aligns with the labeled claim, and impurity profiles are well within the established safety limits, ensuring the product is suitable for its intended therapeutic use and poses no significant risk to patient safety.