Sitagliptin Impurity 85 CAS CATO-C4X-114485
| CAS No. | CATO-C4X-114485 |
| Molecular Formula | C19H25F3N2O4 |
| Molecular Weight | 402.41 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Sitagliptin Impurity 85.
As a process- or degradation-related impurity, Sitagliptin Impurity 85 (CAS CATO-C4X-114485, C19H25F3N2O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution, Sitagliptin Impurity 85 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 402.41 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.
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 | C19H25F3N2O4 |
| Molecular Weight | 402.41 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store in a cool place (≤25°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 | F-containing |
| Nitrogen Atoms | 2 |
Related Sitagliptin Standards
- Sitagliptin Impurity 158 (CAS CATO-C4X-1144158)
- Sitagliptin Impurity 9 (CAS 767340-03-4)
- Sitagliptin Impurity 23 (CAS CATO-C4X-114423)
- Sitagliptin Impurity 24 (CAS CATO-C4X-114424)
- Sitagliptin Impurity 108 (CAS CATO-C4X-1144108)
- Sitagliptin Impurity 109 (CAS CATO-C4X-1144109)
- Sitagliptin Impurity 137 (CAS CATO-C4X-1144137)
- Sitagliptin Impurity 4 (CAS 764667-65-4)
Recommended Standards
- Difloxacin-d3 (methyl-d3) (CAS 1173147-93-7)
- N-(2,4-difluorophenyl)-2-(N-phenylphenylsulfonamido)acetamide (CAS 339102-95-3)
- N-(2,3-Dihydro-1,4-benzodioxin-6-ylsulfonyl)tryptophan (CAS 1008587-24-3)
- 9,9-Dimethyl-6-(4-(trifluoromethoxy)phenyl)-5,6,8,9,10,11-hexahydro-7H-dibenzo[b,e][1,4]diazepin-7-one (CAS 444151-02-4)
- Malic Acid Impurity 4 (CAS 56235-92-8)
- Perampanel Impurity 19 (CAS CATO-C4X-243019)
- Cefpodoxime Proxetil Impurity 18 (CAS CATO-C4X-157918)
- 2-Ethylhexan-1-amine hydrobromide (CAS 88358-65-0)
- DL-2-Fluoroamphetamine hydrochloride (CAS 1626-69-3)
- 7-methoxyquinoxalin-2-amine (CAS 951240-20-3)
- 3-(4-Methoxyphenyl)-5-methylisoxazole-4-carbaldehyde (CAS 273223-12-4)
- 4-(4-Oxocyclohexyl)benzamide (CAS 73204-06-5)
- Tert-butyl (5-oxo-4-azaspiro[2.6]Nonan-6-yl)carbamate (CAS 1822546-02-0)
- Liraglutide Impurity 6 TFA Salt (CAS CATO-C4X-19926)
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