Insulin Degludec Impurity 1 CAS 843666-26-2
| CAS No. | 843666-26-2 |
| Molecular Formula | C33H56N2O9 |
| Molecular Weight | 624.81 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.
CATO supplies Insulin Degludec Impurity 1 (CAS 843666-26-2), a pharmacopoeial impurity reference standard (molecular formula C33H56N2O9, MW 624.81 g/mol) used for the identification and quantification of trace impurities in APIs.
Insulin Degludec Impurity 1 (C33H56N2O9) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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 | C33H56N2O9 |
| Molecular Weight | 624.81 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) | 7.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1987 |
| Nitrogen Atoms | 2 |
Related Insulin Standards
- Insulin Degludec Impurity 3 (CAS CATO-C4X-21573)
- Insulin Degludec Impurity 7 (CAS CATO-C4X-21577)
- Insulin Degludec Impurity 5 (CAS CATO-C4X-21575)
- Insulin Degludec Impurity 8 (CAS CATO-C4X-21578)
- Insulin Degludec Impurity 17 (CAS CATO-C4X-215717)
- Insulin Degludec Impurity 18 (CAS CATO-C4X-215718)
- Insulin Degludec Impurity 13 (CAS CATO-C4X-215713)
- Insulin Degludec Impurity 19 (CAS CATO-C4X-215719)
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