Sugammadex Impurity 65 CAS CATO-C4X-190665
| CAS No. | CATO-C4X-190665 |
| Molecular Formula | C48H71Br7O32 |
| Molecular Weight | 1719.39 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Sugammadex Impurity 65.
As a process- or degradation-related impurity, Sugammadex Impurity 65 (CAS CATO-C4X-190665, C48H71Br7O32) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Sugammadex Impurity 65 (C48H71Br7O32) contains a carboxylic acid group, a hydroxyl group, an ether linkage, bromine substitution, a polycyclic aromatic system. The molecule exhibits a degree of unsaturation (DBE) of 10.0, corresponding to approximately 10 ring(s) or double-bond equivalent(s). With a molecular weight of 1719.39 g/mol, it falls into the high-molecular-weight range. 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.
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 | C48H71Br7O32 |
| Molecular Weight | 1719.39 g/mol |
| Purity | >90% |
| Storage | Store at room temperature, 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; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Br-containing |
Related Sugammadex Standards
- Sugammadex Impurity 52 (CAS 2458187-21-6)
- Sugammadex Impurity 61 (CAS 53784-84-2)
- Sugammadex Impurity 64 (CAS CATO-C4X-190664)
- Sugammadex Impurity Org210839-1 (CAS CATO-C4X-19064)
- Sugammadex Impurity N14 (CAS 53784-83-1)
- Sugammadex Impurity Org46643 (CAS CATO-C4X-190616)
- Sugammadex Impurity 41 (CAS CATO-C4X-190641)
- Sugammadex Impurity Org244517-1 (CAS 3052554-61-4)
Recommended Standards
- Dalbavancin Impurity 55 (CAS CATO-C4X-160255)
- Senegin IV (CAS 51005-46-0)
- Dalbavancin Impurity 54 (CAS CATO-C4X-160254)
- Cortistatin-14 (CAS 186901-48-4)
- Insulin Degludec Impurity 16 (CAS CATO-C4X-215716)
- Posaconazole Impurity 15(S,S,S,S) (CAS 1246391-73-0)
- Trametinib Impurity N2 (CAS 871701-39-2)
- 4-((2-Methylallyl)oxy)benzaldehyde (CAS 38002-91-4)
- 2,3,4,6-Tetrafluorobenzeneboronic acid (CAS 511295-00-4)
- 1-(3-Chlorophenyl)cyclopentanecarboxamide (CAS 1330750-31-6)
- 1-((4-(Nonyloxy)phenyl)amino)anthracene-9,10-dione (CAS 75395-76-5)
- 3,4-Dichloro-N-[2-(pyridin-3-yl)pyrimidin-4-yl]benzamide (CAS 866143-28-4)
- 7-Amino-4,6-dimethylquinolin-2(1H)-one (CAS 58336-28-0)
- Semaglutide impurity 85 (CAS CATO-C4X-222685)
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