| CAS No.: | 1415456-99-3 |
|---|---|
| Formula: | C2825 H34n480 |
| Type: | Pharmaceutical Intermediates |
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| Product Name | Tirzepatid | ||
| 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. | 2023 | Batch Quantity | 1013.1g |
| Molecular Formula | C225H348N48 | 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 |
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