Insulin Degludec Impurity 15 CAS CATO-C4X-215715
| CAS No. | CATO-C4X-215715 |
| Molecular Formula | C24H38N2O9 |
| Molecular Weight | 498.57 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Insulin Degludec Impurity 15 is closely related to a flavonoid core, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
As a process- or degradation-related impurity, Insulin Degludec Impurity 15 (CAS CATO-C4X-215715, C24H38N2O9) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Insulin Degludec Impurity 15 (C24H38N2O9) is characterized by a flavonoid core, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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.
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 | C24H38N2O9 |
| Molecular Weight | 498.57 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| 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) | 7.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 2 |
Related Insulin Standards
- Insulin Degludec Impurity 14 (CAS CATO-C4X-215714)
- Insulin Degludec Impurity 10 (CAS CATO-C4X-215710)
- Insulin Degludec Impurity 12 (CAS CATO-C4X-215712)
- Insulin Degludec Impurity 24 (CAS CATO-C4X-215724)
- Insulin Degludec Impurity 26 (CAS CATO-C4X-215726)
- Insulin B (22-25) (CAS 34367-73-2)
- Insulin Degludec Impurity 25 (CAS CATO-C4X-215725)
- Insulin Degludec Impurity 28 (CAS CATO-C4X-215728)
Recommended Standards
- Finerenone Impurity 200 (CAS CATO-C4X-2880200)
- Conivaptan Impurity 5 (CAS CATO-C4X-13605)
- Finerenone Impurity 228 (CAS CATO-C4X-2880228)
- N'1,N'12-Bis(2-hydroxybenzoyl)dodecanedihydrazide (CAS 63245-38-5)
- Clopidogrel Impurity 6 (CAS 1357474-92-0)
- Uridine Impurity 6 (CAS CATO-C4X-23346)
- Bilastine Impurity 23 (CAS CATO-C4X-225323)
- 1-(3-Chloro-1,4-dioxo-1,4-dihydronaphthalen-2-yl)-N'-(3-chloro-5-(trifluoromethyl)pyridin-2-yl)-N'-methylpiperidine-4-carbohydrazide (CAS 444151-84-2)
- Promethazine Impurity 30 (CAS 3568-81-8)
- 2-(5-(P-tolyl)oxazol-2-yl)ethan-1-amine (CAS 1017366-09-4)
- 3-Amino-n-methyl-n-phenylbenzene-1-sulfonamide (CAS 6374-99-8)
- 5-Chloro-2-(3-methoxybenzyl)benzaldehyde (CAS 2699792-49-7)
- 2-(4-(2-(1H-Imidazol-1-yl)ethoxy)phenyl)ethanol (CAS 99761-74-7)
- Semaglutide impurity 204 (CAS CATO-C4X-2226204)
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