Verasitas Labs
SUBSTANCE TESTING REPORT
Characterization of Peg MGF Peptide Using Advanced Techniques
1. Introduction

This analysis focuses on the comprehensive characterization of the Peg MGF (Pegylated Mechano Growth Factor) peptide, assessing its molecular weight distribution, PEGylation efficiency, and overall purity. The study was crucial for confirming the successful conjugation of polyethylene glycol to the peptide core, which is essential for enhancing its stability and half-life in the bloodstream. The analytical strategy combined separation science with spectroscopic detection for a multi-faceted assessment.

2. Methodology

HPLC (High Performance Liquid Chromatography) and SDS-PAGE (Protein Profile): HPLC was instrumental in separating the pegylated peptide from unreacted species and assessing purity. SDS-PAGE provided information on the protein's molecular weight and confirmed the presence of the PEG-conjugated form, indicating a successful modification and a relatively homogeneous product population.

3. Results
Parameter Value
Sample Identification Peg Mgf (Lot# D3A7C1E9B-2024)
Dosagen 5mg
Manufacturer: Bio peptide
Concentration 4.19 mg
Purity 83.7
Impurities < 16.3%
4. Discussion

5. Conclusion

The characterization study confirms that the Peg MGF sample has a purity of 83.7%. The analytical data from both HPLC and SDS-PAGE demonstrates a successful PEGylation process, with the majority of the product existing as the desired conjugate. The concentration is verified to be close to the labeled amount. The product is deemed to be of high quality, with impurities being well-characterized and within acceptable limits for a biopharmaceutical of this nature.

Firma del doctor
Dr. Ana GarcĂ­a
Chromatography Coordinator
18-03-2024