Purification Process of Tirzepatide By Xtimate C8

Tirzepatide is a medication that acts simultaneously on GIP and 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 Zepbound (Tirzepatide) injection, 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 glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors.

Sharing the Purification Processes for Two Batches of Tirzepatide Active Pharmaceutical Ingredients with Different Purity Levels

Case One - Crude Peptide purity 74.95%

Figure 1. Spectrum of Sample One: Raw Material Analysis

Purification Process as follows:

Primary Purification

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

Figure 2. Spectrum of 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

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

Figure 3. Spectrum of 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.