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Tirzepatide Purification

Tirzepatide Purification Report

BBN-GLP1-TIR-001 August 2025

 Primary Purification

Preparation Chromatogram

Purification Method

Column Sunpure-HS C8 Pro 10µm 100Å
Item Number HST102000-0
Sample Tirzepatide crude
Loading Capacity 1%
Flow Rate 3mL/min
Mobile Phase A: 0.1% TFA in water | B: 0.1% TFA in ACN

Purification Results

99.73%
Purity
72.90%
Recovery
0.27%
Max Single Impurity

Conclusion

The single-step purification process achieves pharmaceutical-grade tirzepatide:

Key Results

  • Final purity: 99.73% (exceeds pharmacopeial requirements)
  • Recovery rate: 72.90% from crude material
  • Maximum single impurity: 0.27%
  • Loading capacity maintained at 1%

Product Characteristics

  • Novel dual GIP/GLP-1 receptor agonist
  • Binds albumin to prolong half-life
  • Enhances both phases of insulin secretion
  • Reduces glucagon levels glucose-dependently
  • Promotes weight loss in T2DM patients

Performance Summary

Purity: 99.73% (HPLC)
Recovery: 72.90%
Impurity Profile: All <0.3%

Note: The Sunpure-HS C8 Pro material demonstrated excellent performance for tirzepatide purification, delivering high purity in a single chromatographic step. The method is robust and suitable for large-scale production of this dual agonist peptide therapeutic.

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