Certificate of analysis
| Product Name | GLP&GIP Peptide | ||
| Batch No.: | CP-027-20240910 | Molecular weight | 4813.4514 |
| Molecular Formula | C225H348N48O68 | Quantity | 1893.85 |
| Manufacturing Date | 2024/09/10 | Expiration Date | 2026/09/09 |
| Test Items | Specifications | Results |
| Appearance | White to coff white powder | Conforms |
| Solubility | Freely soluble in water | Conforms |
Identification | The retention time of the main principal of the test Solution corresponds to that of the reference Solution, as obtained in the assay | Comform |
| PH | 6.0 to 9.0 | 7.1 |
| Clarity and color of the solution | The solution should be clear and colorless | Comform |
| Water content(K.F) | Not more than 7.0% | 3.2% |
| Acetic acid | Not more than 0.5% | 0.1% |
| Trifioroacetate ion | Not more than 0.5% | 0.002% |
| Sodium ion | Not more than 5.0% | 1.4% |
| Amino acid ratio | i.Ser 4.0 to 6.0 | Comforms |
| Ii.Asp 1.6 to 2.4 |
| ii.Thr 1.6 to 2.4 | ||
| Iv.Pro 3.2 to 4.8 | ||
| V.Tyr 1.6 to 2.4 | ||
| Vi.Leu 1.6 to 2.4 | ||
| Vii Glue 2.4 to 3.5 | ||
| Ix Ala 3.2 to 4.8 | ||
| x.Lys 1.6 to 2.4 | ||
| Xi.Ile 2.4to 3.6 | ||
| Xii. Phe 1.6 to 2.4 | ||
| Xiii val 0.8 to 1.2 | ||
| Related substances | Maximum single impurity:Not more than 0.5% | 0.29% |
| Total impurities:Not more thn 1.0% | 0.91 | |
| Purity(HPLC) | Not less than 99.0% | 99.1% |
| Impurities with molecular masses grater than that of tirzepatide | Maximum single impurity:Not more than 0.5% | 0.02% |
| Total impurities:Not more than 1.0% | 0.02% | |
| Bacterial Eenotoxin test | Not more than 5EU/MG | Conforms |
| Assay | 95.0%~ 105.0% | 97.2% |
| Assay ofpeptide | Not less than 85% | 94.3% |
| Conclusion | The Product conforms to In-house Standard | |
| Storage: Pressure in an airtight,closed container protected from light | ||
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