Sitagliptin Impurity 76 CAS 209995-38-0
| CAS No. | 209995-38-0 |
| Molecular Formula | C8H5F3O2 |
| Molecular Weight | 190.12 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.
Sitagliptin Impurity 76 (CAS 209995-38-0) is a certified pharmaceutical impurity reference standard with the molecular formula C8H5F3O2 and a molecular weight of 190.12 g/mol.
Structurally, Sitagliptin Impurity 76 (C8H5F3O2) contains a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, an aromatic ring system. The molecule exhibits a degree of unsaturation (DBE) of 5.0, corresponding to approximately 5 ring(s) or double-bond equivalent(s). With a molecular weight of 190.12 g/mol, it falls into the medium-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
As a certified reference material (CRM), Sitagliptin Impurity 76 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 | C8H5F3O2 |
| Molecular Weight | 190.12 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >95% |
| Storage | Store at 2-8°C, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2016 |
| Halogen Content | F-containing |
Related Sitagliptin Standards
- Sitagliptin Impurity 111 (CAS 1335952-08-3)
- Sitagliptin Impurity 122 (CAS CATO-C4X-1144122)
- Sitagliptin Impurity N31 (CAS 910409-20-0)
- Sitagliptin Impurity 63 (CAS 1864680-46-5)
- Sitagliptin Impurity 60 (CAS 1305324-02-0)
- Sitagliptin Impurity 80 (CAS 220199-85-9)
- Sitagliptin Impurity 62 (CAS 723286-98-4)
- Sitagliptin Impurity 107 (CAS 89124-06-1)
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