Insulin Degludec Impurity 27 CAS CATO-C4X-215727
| CAS No. | CATO-C4X-215727 |
| Molecular Formula | C52H91N5O16 |
| Molecular Weight | 1042.30 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The molecular framework of Insulin Degludec Impurity 27 (C52H91N5O16) is characterized by a nitrogen-containing heterocyclic scaffold, 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).
As a process- or degradation-related impurity, Insulin Degludec Impurity 27 (CAS CATO-C4X-215727, C52H91N5O16) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
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 manufactures Insulin Degludec Impurity 27 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.
Physical & Chemical Properties
| Molecular Formula | C52H91N5O16 |
| Molecular Weight | 1042.30 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 | 5 |
Related Insulin Standards
- 103244-41-3 Insulin-like Growth Factor-II fragment 33-40 Ser-Arg-Val-Ser-Arg-Arg-Ser-Arg (CAS 103244-41-3)
- Insulin Degludec Impurity 2 (CAS CATO-C4X-21572)
- Insulin Degludec Impurity 6 (CAS CATO-C4X-21576)
- Insulin Degludec Impurity 7 (CAS CATO-C4X-21577)
- Insulin Degludec Impurity 1 (CAS 843666-26-2)
- Insulin Degludec Impurity 3 (CAS CATO-C4X-21573)
- Insulin Degludec Impurity 5 (CAS CATO-C4X-21575)
- Insulin Degludec Impurity 8 (CAS CATO-C4X-21578)
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Why CATO?
- ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
- 130,000+ catalog items in stock, COA supplied with every batch
- Worldwide shipping with full export documentation (HS code guidance available)
- Technical support: +86 18665070610 / Nicole.chen@cato-chem.com