This extensive analysis evaluates the Somatropin formulation to assess its biological activity, purity profile, and concentration accuracy. The investigation employs sophisticated analytical methodologies to ensure the product meets rigorous quality standards for recombinant growth hormone preparations.

Mass spectrometry and SDS-PAGE: Mass spectrometry provides precise molecular weight determination and purity assessment, while SDS-PAGE electrophoresis offers protein profile characterization through molecular separation and staining techniques.

The analytical results demonstrate that the Somatropin formulation exhibits outstanding purity levels at 95.8%, well within the specified range for high-quality biopharmaceutical products. Mass spectrometric analysis confirmed the correct molecular weight and showed minimal degradation products. Electrophoretic separation revealed a single major band corresponding to somatropin with negligible contaminating proteins, indicating superior purification and manufacturing quality control throughout the production process.

The Somatropin formulation meets all established quality specifications with exceptional purity levels and accurate concentration values. The product demonstrates excellent biological integrity and manufacturing consistency, confirming its suitability for therapeutic applications requiring high-purity growth hormone preparations meeting stringent regulatory standards.