Alogliptin Impurity 36 CAS 4318-56-3
| CAS No. | 4318-56-3 |
| Molecular Formula | C5H5ClN2O2 |
| Molecular Weight | 160.56 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
As a process- or degradation-related impurity, Alogliptin Impurity 36 (CAS 4318-56-3, C5H5ClN2O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Alogliptin Impurity 36 (C5H5ClN2O2) is characterized by an amide group, a carboxylic acid 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 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).
As a certified reference material (CRM), Alogliptin Impurity 36 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
Physical & Chemical Properties
| Molecular Formula | C5H5ClN2O2 |
| Molecular Weight | 160.56 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor) |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry, keep tightly closed to prevent evaporation |
| 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) | 4.0 |
| UV Absorption | UV-absorbing |
| CAS Registry Year (est.) | 1958 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |
Related Alogliptin Standards
- Alogliptin Related Compound 33 (CAS 4187-53-5)
- Alogliptin Related Compound 34 (CAS 22038-87-5)
- Alogliptin Impurity 41 (CAS 3177-80-8)
- Alogliptin Impurity 55 (CAS 6705-03-9)
- Alogliptin Impurity 38 (CAS 120977-94-8)
- Alogliptin Impurity 39 (CAS 6297-80-9)
- Alogliptin Related Compound 49 (CAS 33832-98-3)
- Alogliptin Impurity 69 (CAS 1243378-31-5)
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