| CAS No. | 168749-30-2 |
| Molecular Formula | C6H12N2O |
| Molecular Weight | 128.17 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Linagliptin Impurity 92.
As a process- or degradation-related impurity, Linagliptin Impurity 92 (CAS 168749-30-2, C6H12N2O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Linagliptin Impurity 92 (C6H12N2O) contains an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 2.0, corresponding to approximately 2 ring(s) or double-bond equivalent(s). With a molecular weight of 128.17 g/mol, it falls into the low-molecular-weight range. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
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 certified reference material (CRM), Linagliptin Impurity 92 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.
| Molecular Formula | C6H12N2O |
| Molecular Weight | 128.17 g/mol |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 2.0 |
| CAS Registry Year (est.) | 2005 |
| Nitrogen Atoms | 2 |