| CAS No. | CATO-C4X-21574 |
| Molecular Formula | C21H35NO6 |
| Molecular Weight | 397.51 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Compared with other compounds in its class, the molecular weight of 397.51 g/mol gives Insulin Degludec impurity 4 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
CATO supplies Insulin Degludec impurity 4 (CAS CATO-C4X-21574), a pharmacopoeial impurity reference standard (molecular formula C21H35NO6, MW 397.51 g/mol) used for the identification and quantification of trace impurities in APIs.
Based on its molecular formula C21H35NO6, Insulin Degludec impurity 4 contains a steroid core, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 397.51 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.
As a certified reference material (CRM), Insulin Degludec impurity 4 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 | C21H35NO6 |
| Molecular Weight | 397.51 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 1 |