Liraglutide Purification Report
Primary Purification
Primary Chromatogram
Primary Purification Method
| Column | Sunpure-HS C8 Pro 10µm 100Å |
| Injection | Crude liraglutide |
| Detection | 210nm / 280nm |
| Mobile Phase | A: 0.1% TFA in water | B: 0.1% TFA in ACN |
| Flow Rate | 3mL/min |
| Loading Capacity | 1% |
Primary Purification Results
99.77%
Purity
74.79%
Recovery
0.23%
Max Single Impurity
Conclusion
The single-step purification process achieves pharmaceutical-grade liraglutide:
Key Results
- Final purity: 99.77% (exceeds pharmacopeial requirements)
- Recovery rate: 74.79% from crude material
- Maximum single impurity: 0.23%
- Loading capacity maintained at 1%
Method Highlights
- Sunpure-HS C8 Pro column demonstrated excellent performance
- Optimized flow rate of 3mL/min
- TFA-based mobile phase system
- 210nm primary detection wavelength
Performance Summary
Purity: 99.77% (HPLC)
Recovery: 74.79%
Impurity Profile: All <0.25%
Note: The Sunpure-HS C8 Pro material proved ideal for liraglutide purification, delivering high purity in a single chromatographic step. The method is robust and scalable for production purposes.