Tirzepatide

Tirzepatide Purification by Xtimate C8

Tirzepatide is a medication that acts simultaneously on glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide-1 (GLP-1). In May 2022, Tirzepatide received FDA approval for marketing and was used for the treatment of diabetes, while also obtaining fast-track qualification for obesity. 

On November 8, 2023, Eli Lilly announced that the FDA had approved their tirzepatide injection called Zepbound, marking the official entry of Eli Lilly's Tirzepatide into the chronic weight management market.

This is the first and only medication for obesity treatment that acts as a dual agonist of GIP and GLP-1 receptors.

Process Optimization for Purifying Two Batches of Tirzepatide API with Different Purity Levels

Application 1: Crude Peptide (purity: 74.95%)

Figure 1. Chromatogram of Crude Peptide Sample before Purification
Figure 1. Chromatogram of Crude Peptide Sample before Purification

Purification Process:

Primary Purification

Packing Material: Xtimate® C8, 10μm, 120Å

Figure 2. Chromatogram of Crude Peptide Sample after Primary Purification
Figure 2. Chromatogram of Crude Peptide Sample after Primary Purification

Results: After primary purification, purity reached 92.44%, with a recovery rate of 75%. The loading volume was 0.5% of the Packing Materials volume.

Secondary Purification

Packing Material: Xtimate® C8, 10μm, 120Å

Figure 3. Chromatogram of Crude Peptide Sample after Secondary Purification
Figure 3. Chromatogram of Crude Peptide Sample after Secondary Purification

Results: After secondary purification, purity reached 99.21%, with a recovery rate of 50%. The loading volume was 0.4% of the Packing Materials volume.

Application 2: Crude Peptide (purity: 41.11%)

Figure 4. Chromatogram of Crude Peptide Sample before Purification
Figure 4. Chromatogram of Crude Peptide Sample before Purification

Purification Process:

Primary Purification

Packing Material: Xtimate® C8, 10μm, 120Å

Figure 5. Chromatogram of Crude Peptide Sample after Primary Purification
Figure 5. Chromatogram of Crude Peptide Sample after Primary Purification

Results: After purification, the purity reached 79.63%, with a recovery rate of 50%. The loading volume was 0.2% of the Packing Materials volume.

Secondary Purification

Packing Material: Xtimate® C8, 10μm, 120Å

Figure 6. Chromatogram of Crude Peptide Sample after Secondary Purification
Figure 6. Chromatogram of Crude Peptide Sample after Secondary Purification

Results: After purification, the purity reached 99.95%, with a recovery rate of 60%. The loading volume was 0.1% of the Packing Material volume.

HPLC Column Xtimate C8 Packing Material

Data:

Data Sample 1 (%) Sample 2 (%)
Purity of crude peptide 74.95 41.11
Purity after primary purification 92.44 79.63
Recovery rate of primary purification 75 50
Injection volume of primary purification 0.5 0.2
Purity after secondary purification 99.21 99.95
Recovery rate of secondary purification 50 60
Injection volume of secondary purification 0.4 0.1