Saxagliptin Impurity 27 CAS CATO-C4X-104927
| CAS No. | CATO-C4X-104927 |
| Molecular Formula | C20H30N2O4 |
| Molecular Weight | 362.46 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 Saxagliptin Impurity 27.
CATO supplies Saxagliptin Impurity 27 (CAS CATO-C4X-104927), a pharmacopoeial impurity reference standard (molecular formula C20H30N2O4, MW 362.46 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Saxagliptin Impurity 27 (C20H30N2O4) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 7.0, corresponding to approximately 7 ring(s) or double-bond equivalent(s). With a molecular weight of 362.46 g/mol, it falls into the moderately-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 | C20H30N2O4 |
| Molecular Weight | 362.46 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 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 Saxagliptin Standards
- Saxagliptin Impurity 82 (CAS CATO-C4X-104982)
- Saxagliptin Impurity 93 (CAS 1642872-42-1)
- Saxagliptin Impurity 85 (CAS CATO-C4X-104985)
- Saxagliptin Impurity 16 (CAS CATO-C4X-104916)
- Saxagliptin impurity 78 (CAS CATO-C4X-104978)
- Saxagliptin Impurity 90 (CAS CATO-C4X-104990)
- Saxagliptin Impurity 19 (CAS 681282-72-4)
- Saxagliptin Impurity 86 (CAS CATO-C4X-104986)
Recommended Standards
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