| Customization: | Available |
|---|---|
| Appearance: | Powder |
| Colour: | White |
|
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CERTIFICATE OF ANALYSIS
| Product Name | Tirzepatide (LY3298176) | ||
| Sequence | Tyr-{Aib}-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Tyr-Ser-Ile-{Aib}-Leu- Asp-Lys-Ile-Ala-Gln-{diacid-gamma-Glu-(AEEA)2-Lys}-Ala-Phe-Val-Gln-Trp-Leu-Ile-Ala-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2 | ||
| Quality Standard | In-house | Batch No. | ZB10023106 |
| CAS No. | 2023788-19-2 | Batch Quantity | 1013.1g |
| Molecular Formula | C225H348N48O | Manufacturing Date | 24-Aug-2023 |
| Molecular Mass | 4813.45 | Retest Date | 24-Aug-2025 |
| Tests | Specifications | Results | |
| Characters | Appearance | White to almost white loose powder | White loose powder |
| Solubility | Soluble in water | Complies | |
| Identifications | HPLC | The retention time of the major peak in the chromatogram of the test solution corresponds to that in the chromatogram of the Reference Solution, as obtained in the Assay | Complies |
| MALDI-MS | 4813.5±1.0 Da | 4812.6 Da | |
| Amino acid analysis | Ser: 4.0-6.0 | 4.6 | |
| Asp: 1.6-2.4 | 1.6 | ||
| Thr: 1.6-2.4 | 1.8 | ||
| Pro: 3.2-4.8 | 4.1 | ||
| Tyr: 1.6-2.4 | 2.1 | ||
| Leu: 1.6-2.4 | 1.9 | ||
| Gly: 3.2-4.8 | 4.0 | ||
| Glu: 3.2-4.8 | 3.8 | ||
| Ala: 3.2-4.8 | 3.9 | ||
| Lys: 1.6-2.4 | 1.9 | ||
| Ile: 2.4-3.6 | 3.0 | ||
| Phe: 1.6-2.4 | 2.2 | ||
| Peptide Purity (HPLC) | ≥ 80% | 93.6% | |
| Related Substances | Impurities (HPLC) | Any unspecified impurity ≤ 0.10% | 0.06% |
| Toal impurities ≤ 0.50% | 0.12% | ||
| Oligomer | ≤ 3.0% | 0.27% | |
| Water content (KF) | ≤ 8.0% | 4.63% | |
| Sodium ion | Report | 1.1% | |
| Residual solvents (GC) | Acetonitril-e ≤ 410 ppm | 246 ppm | |
| Bacterial Endotoxins | ≤ 10 EU/mg | Complies | |
| Microbiology | Total aerobic microbial count | ≤ 100 CFU/g | < 10 CFU/g |
| Total combined yeasts and moulds count | ≤ 100 CFU/g | < 10 CFU/g | |
| Escherichia coli count | Absent in 1g | Complies | |
| Assay | Calculated as C18H14F4N2O4S on dried substance | 98.0% - 102.0% | 99.8% |
| Storage condition: | 2°C - 8°C, well-closed containers, protected from light. |
| Remarks: | This batch of product COMPLIES with the prescribed standards. |
| Analysed on: | 18.09.2023 |
FAQ
1. How to preserve peptides after receiving them?
Peptides in the form of lyophilized powder can be transported at room temperature by vacuum packaging, while polypeptides in the dissolved state need to be refrigerated at 2°C - 8°C. For long-term storage, peptides should be stored in the form of lyophilized powder stored at -20°C or -80°C in a sealed container with desiccant, which can avoid the degradation of peptides to the greatest extent.
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