This detailed assessment investigates the Zenosim growth hormone formulation to determine its chemical purity, biological activity, and overall quality parameters. The analysis utilizes advanced analytical techniques to verify product quality and compliance with pharmaceutical standards for recombinant growth hormone products.
GC-MS and Functional Biological Assay: Gas Chromatography-Mass Spectrometry provides accurate compound identification and purity assessment, while Functional Biological Assay evaluates the biological activity and potency through specific cellular response measurements for comprehensive quality assessment.
| Parameter | Value |
|---|---|
| Sample Identification | Zenosim (Lot# 682947315-MNO-2024) |
| Dosagen | 3.7 mg |
| Manufacturer: | Novocrine |
| Concentration | 3.09 mg |
| Purity | 83.4 |
| Impurities | < 16.6% |
The analytical evaluation indicates that the Zenosim formulation demonstrates good purity levels at 83.4%, within acceptable ranges for growth hormone preparations. Chromatographic analysis showed well-defined peaks corresponding to the active hormone with minimal interference from excipients or degradation products. The biological activity assessment confirmed appropriate potency levels, and concentration determination revealed consistent values across multiple sample analyses, indicating proper manufacturing control and product homogeneity throughout production batches.
The Zenosim formulation satisfies quality requirements with acceptable purity levels and accurate concentration values. The product exhibits appropriate biological activity and manufacturing consistency, confirming its suitability for therapeutic applications requiring reliable growth hormone preparations and meeting the necessary standards for clinical use in hormone replacement therapies.
