Sitagliptin Impurity N31 CAS 910409-20-0
| CAS No. | 910409-20-0 |
| Molecular Formula | C9H10F3N |
| Molecular Weight | 189.18 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Sitagliptin Impurity N31 (CAS 910409-20-0, C9H10F3N) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to a nitrogen-containing heterocyclic scaffold, a nitrile group, fluorine substitution, Sitagliptin Impurity N31 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 189.18 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 | C9H10F3N |
| Molecular Weight | 189.18 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1987 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |
Related Sitagliptin Standards
- Sitagliptin Impurity 111 (CAS 1335952-08-3)
- Sitagliptin Impurity 122 (CAS CATO-C4X-1144122)
- Sitagliptin Impurity 63 (CAS 1864680-46-5)
- Sitagliptin Impurity 76 (CAS 209995-38-0)
- 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)
Recommended Standards
- 5,6-Diaminopyridine-3-sulfonic acid (CAS 100517-08-6)
- 4-fluoro-7H-pyrrolo[2,3-d]pyrimidine-6-carboxylic acid (CAS 1016241-81-8)
- N-Methyl-1-(4-(trifluoromethyl)phenyl)methanamine (CAS 90390-11-7)
- 6-(4-Fluorophenyl)pyrimidin-4-amine (CAS 1036990-57-4)
- Doripenem Impurity 5 (CAS 189188-38-3)
- Flomoxef Impurity 41 (CAS CATO-C4X-138241)
- Phenylephrine Impurity 52 (CAS 1785420-81-6)
- 5-Bromo-2-(furan-2-yl)pyrimidine-4-carboxylic acid (CAS 1240598-46-2)
- Boc-L-1,2,3,4-tetrahydronorharman-3-carboxylic acid (CAS 66863-43-2)
- 3-Methyl-4-(1h-pyrrol-1-yl)benzoic acid (CAS 593272-74-3)
- Bromoacetylcholine (bromide) (CAS 22004-27-9)
- N-(7-Propyl-[1,3]dioxolo[4',5':4,5]benzo[1,2-d]thiazol-6(7H)-ylidene)cyclohexanecarboxamide (CAS 898464-32-9)
- 5-nitro-2,3-dihydro-1H-inden-1-one (CAS 22246-24-8)
- Semaglutide impurity 91 (CAS CATO-C4X-222691)
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