Tirzepatide Impurity 35 CAS CATO-C4X-324035
| CAS No. | CATO-C4X-324035 |
| Molecular Formula | C235H372N50O73 |
| Molecular Weight | 5065.76 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.
As a process- or degradation-related impurity, Tirzepatide Impurity 35 (CAS CATO-C4X-324035, C235H372N50O73) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Tirzepatide Impurity 35 (C235H372N50O73) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 75.0, corresponding to approximately 75 ring(s) or double-bond equivalent(s). With a molecular weight of 5065.76 g/mol, it falls into the high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.
Physical & Chemical Properties
| Molecular Formula | C235H372N50O73 |
| Molecular Weight | 5065.76 g/mol |
| Purity | ≥95% |
| Storage | Store in a cool place (≤25°C), protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 75.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 50 |
Related Tirzepatide Standards
- Tirzepatide Impurity 61 (CAS CATO-C4X-324061)
- Tirzepatide Impurity 34 (CAS CATO-C4X-324034)
- Tirzepatide Impurity 36 (CAS CATO-C4X-324036)
- Tirzepatide Impurity 38 (CAS CATO-C4X-324038)
- Tirzepatide Impurity 57 (CAS CATO-C4X-324057)
- Tirzepatide Impurity 37 (CAS CATO-C4X-324037)
- Tirzepatide (CAS 2023788-19-2)
- [Nva12]-Tirzepatide (CAS CATO-C4X-324042)
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