Saxagliptin Impurity 21 CAS 871727-40-1
| CAS No. | 871727-40-1 |
| Molecular Formula | C13H21NO4 |
| Molecular Weight | 255.31 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Compared with other compounds in its class, the molecular weight of 255.31 g/mol gives Saxagliptin Impurity 21 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
Saxagliptin Impurity 21 (CAS 871727-40-1) is a certified pharmaceutical impurity reference standard with the molecular formula C13H21NO4 and a molecular weight of 255.31 g/mol.
Structurally, Saxagliptin Impurity 21 (C13H21NO4) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 4.0, corresponding to approximately 4 ring(s) or double-bond equivalent(s). With a molecular weight of 255.31 g/mol, it falls into the medium-molecular-weight range. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
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 | C13H21NO4 |
| Molecular Weight | 255.31 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 methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1987 |
| Nitrogen Atoms | 1 |
Related Saxagliptin Standards
- Saxagliptin Impurity 23 (CAS 214193-10-9)
- Saxagliptin Impurity 49 (CAS 214193-11-0)
- Saxagliptin Impurity 22 (CAS CATO-C4X-104922)
- Saxagliptin Impurity 70 (CAS CATO-C4X-104970)
- Saxagliptin Impurity 73 (CAS CATO-C4X-104973)
- Saxagliptin Impurity 72 (CAS CATO-C4X-104972)
- Saxagliptin Impurity 47 (CAS 197142-36-2)
- Saxagliptin Impurity 20 (CAS 1564266-79-0)
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