| CAS No. | 220199-85-9 |
| Molecular Formula | C9H17NO3 |
| Molecular Weight | 187.24 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
As a certified reference material (CRM), Sitagliptin Impurity 80 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.
CATO supplies Sitagliptin Impurity 80 (CAS 220199-85-9), a pharmacopoeial impurity reference standard (molecular formula C9H17NO3, MW 187.24 g/mol) used for the identification and quantification of trace impurities in APIs.
The molecular framework of Sitagliptin Impurity 80 (C9H17NO3) is characterized by an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. 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. 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.
| Molecular Formula | C9H17NO3 |
| Molecular Weight | 187.24 g/mol |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO |
| Stability | Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 2.0 |
| CAS Registry Year (est.) | 2019 |
| Nitrogen Atoms | 1 |