| CAS No. | CATO-C4X-324014 |
| Molecular Formula | C29H44N4O10 |
| Molecular Weight | 608.68 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Tirzepatide Impurity 14.
CATO supplies Tirzepatide Impurity 14 (CAS CATO-C4X-324014), a pharmacopoeial impurity reference standard (molecular formula C29H44N4O10, MW 608.68 g/mol) used for the identification and quantification of trace impurities in APIs.
Based on its molecular formula C29H44N4O10, Tirzepatide Impurity 14 contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 608.68 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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 certified reference material (CRM), Tirzepatide Impurity 14 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
| Molecular Formula | C29H44N4O10 |
| Molecular Weight | 608.68 g/mol |
| Purity | 97%+ |
| 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) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 4 |