Semaglutide purification process sharing
Semaglutide, also known as somarutide, is a medication primarily utilized for the treatment of diabetes. Despite its intended use in diabetes management, it has gained popularity among non-diabetic individuals as a weight-loss aid, often recognized in the public domain as a “miracle drug” for weight reduction.
The current production process of semaglutide involves the combination of biological fermentation and chemical synthesis methods to achieve the product’s preparation. Using this approach, there is a propensity to generate a significant amount of unintended impurities, which hinders subsequent purification processes and results in relatively low recovery rates. Another production method involves traditional peptide solid-phase synthesis coupled with fragment condensation synthesis
Full Synthetic Semaglutide at Two Different Purity Levels: Insights into Purification Processes
Case Study 1:
Purification Insights for Semaglutide with Initial Peptide Purity at 59.65%
Figure 1. Sample 1 crude product analysis chart
Purification Process Overview:
Primary Purification
Chromatography Column: Ultisil® XB-C8, 10μm, 120Å
Figure 2. Primary purification chromatogram
Results: After the primary purification, the purity reached 94.56%, with a recovery rate of 80% and a sample loading of 0.6% of the column capacity.
Secondary Purification
Chromatography Column: Xtimate® C8, 10μm, 120Å
Figure 3. Secondary purification chromatogram
Results: After secondary purification, the purity was 99.65%, the recovery rate was 71%, and the loading amount was 0.56% of the filler amount.
Case 2:
Crude peptide purity 82.75%
Figure 4. Sample 2 crude product analysis chart
The purification process is as follows:
Chromatographic packing: Ultisil® XB-C8, 10μm, 120Å
Figure 5. Purification profile
Results: After the secondary purification, the purity increased to 99.15%, with a recovery rate of 71% and a sample loading of 0.62% of the column capacity.
Summary
| Name | Sample 1 | Sample 2 |
| Crude product purity % | 59.65 | 82.75 |
| 1Purity % | 94.56 | 99.15 |
| Pure recovery rate % | 80 | 71 |
| % of pure sample loading | 0.6 | 0.62 |
| Secondary purity % | 99.65 | – |
| Secondary purity recovery rate % | 71 | – |
| Second pure sample loading % | 0.56 | – |
For low-purity semaglutide, a two-step purification process was employed using Welch Ultisil® XB-C8, 10μm, 120Å, and Xtimate® C8, 10μm, 120Å columns. The final purity achieved was 99.56%, with a total recovery rate of 56.8%. The sample loading for the first and second purification steps was 0.6% and 0.56% of the column capacity, respectively.
For high-purity semaglutide, a single purification step using Welch Ultisil® XB-C8, 10μm, 120Å column resulted in a purity of 99.15%, with a recovery rate of 71%, and a sample loading of 0.62% of the column capacity.
Filler information
| P/N | Specification Description |
| 02720-03100 | Ultisil® XB-C8，10μm，120Å |
| 01720-03100 | Xtimate® C8，10μm，120Å |