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Liraglutide Purification Chromatography Report

Liraglutide Purification Chromatography Report

BBN-GLP1-LIR-003 March 2023

Chromatogram

Method Parameters

Preparative HPLC
Column CH C18 10-120
Injection Concentration 14g/L
Detection Wavelength 280nm (Main) / 240nm (Monitor)
Mobile Phase A 20mM Tris-HCl pH 8.5
Mobile Phase B Acetonitrile (ACN)
Flow Rate 60mL/min
Gradient Program
0min → 30% B 100min → 45% B

Purification Results

90% → >99%
Crude → Final Purity
<0.5%
Single Unknown Impurity
85%
Process Yield

Process Performance

Stage Purity Impurities Yield
Crude Material 90% Not specified N/A
Primary Purification >99% <0.5% 85%

Conclusion

The developed purification process demonstrates excellent performance for liraglutide purification:

  • High Purity Enhancement: 90% crude material purified to >99% final purity
  • Stringent Impurity Control: Single unknown impurity maintained below 0.5% threshold
  • Efficient Recovery: 85% process yield indicates robust method performance

The CH C18 10-120 column with Tris/ACN mobile phase system proves effective for industrial-scale GLP-1 analog production.

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