Saxagliptin Impurity 31 CAS 1564265-95-7 (free base)
| CAS No. | 1564265-95-7 (free base) |
| Molecular Formula | C18H25N3O2 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Saxagliptin Impurity 31 (CAS 1564265-95-7 (free base)) is a certified pharmaceutical impurity reference standard with the molecular formula C18H25N3O2HCl and a molecular weight of 351.88 g/mol.
The molecular framework of Saxagliptin Impurity 31 (C18H25N3O2HCl) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. 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).
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 | C18H25N3O2 HCl |
| Molecular Weight | 351.88 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor) |
| 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; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 7.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 3 |
Related Saxagliptin Standards
- Saxagliptin Impurity N1 (CAS 102502-64-7)
- Saxagliptin Hydrochloride Dihydrate (CAS 1073057-20-1)
- Saxagliptin Impurity N52 (CAS 1194836-75-3)
- Saxagliptin Cyclic Imidine Impurity (CAS 1194836-77-5)
- (±)-Saxagliptin-13C3 (acetyl-13C2,cyclopropyl-3-13C) (CAS 1246812-44-1)
- Saxagliptin-15N,D2 Hydrochloride (CAS 1309934-06-2)
- Saxagliptin Impurity 60 Mesylate (CAS 1312338-82-1)
- Saxagliptin Impurity 6 (CAS 1334321-39-9)
Recommended Standards
- Etoricoxib Impurity 18 (CAS 1027162-35-1)
- Delafloxacin impurity 39 (CAS CATO-C4X-263739)
- Regadenoson Impurity 24 (CAS 50447-10-4)
- 2,3,8,9-Tetrahydronaphtho[2,3-b][1,4]dioxin-6(7H)-one (CAS 15128-62-8)
- 5,6-Dimethoxyindoline (CAS 15937-07-2)
- 5-Fluoro-4-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)-1-(triisopropylsilyl)-1H-pyrrolo[2,3-b]pyridine (CAS 1241950-72-0)
- Ethyl 3-benzyl-3-azabicyclo[3.1.0]hexane-1-carboxylate (CAS 63618-07-5)
- 8-(4-Bromobenzyl)-2,5-dioxa-8-azaspiro[3.4]Octane (CAS 1556097-34-7)
- Rebamipide impurity 18 (CAS CATO-C4X-152318)
- ([D2]Gly4)-Cholecystokinin Octapeptide (sulfated) ammonium salt (CAS 1926163-74-7)
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