Sitagliptin Impurity 82 CAS 2248445-00-1
| CAS No. | 2248445-00-1 |
| Molecular Formula | C14H14F3NO3 |
| Molecular Weight | 301.26 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 82.
Sitagliptin Impurity 82 (CAS 2248445-00-1) is a certified pharmaceutical impurity reference standard with the molecular formula C14H14F3NO3 and a molecular weight of 301.26 g/mol.
Structurally, Sitagliptin Impurity 82 (C14H14F3NO3) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 7.0, corresponding to approximately 7 ring(s) or double-bond equivalent(s). With a molecular weight of 301.26 g/mol, it falls into the moderately-high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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 | C14H14F3NO3 |
| Molecular Weight | 301.26 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| 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 |
| CAS Registry Year (est.) | 1998 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |
Related Sitagliptin Standards
- Sitagliptin Impurity 160 (CAS CATO-C4X-1144160)
- Sitagliptin Impurity 134 (CAS CATO-C4X-1144134)
- Sitagliptin Impurity 81 (CAS 2248445-08-9)
- Sitagliptin Impurity 135 (CAS 1360872-54-3)
- Sitagliptin Impurity 70 (CAS CATO-C4X-114470)
- Sitagliptin Impurity 71 (CAS CATO-C4X-114471)
- Sitagliptin Impurity 26 (CAS 218609-00-8)
- Sitagliptin related compound 1 (CAS 331763-66-7)
Recommended Standards
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- Leflunomide Impurity 13 (CAS 75706-11-5)
- tert-Butyl 3-(6-formyl-5-(trifluoromethyl)pyridin-3-yl)acrylate (CAS 2851876-24-7)
- Phosmet-oxon (CAS 3735-33-9)
- Dabrafenib Impurity 16 (CAS CATO-C4X-303316)
- Posaconazole impurity 234 (CAS CATO-C4X-1208234)
- Clemastine Impurity 33 (CAS CATO-C4X-183733)
- tert-Butyl (Z)-3-(N'-hydroxycarbamimidoyl)morpholine-4-carboxylate (CAS 519031-82-4)
- n-((4-Bromothiophen-2-yl)methyl)prop-2-en-1-amine (CAS 1040047-22-0)
- Avanafil Impurity 84 (CAS CATO-C4X-111884)
- 2-Bromo-6-(difluoromethyl)-5-methoxypyridine-3-sulfonamide (CAS 1805428-16-3)
- 3-{[2-(2,4-dichlorophenyl)-2-oxoethyl]sulfanyl}-5-methyl-1,2-thiazole-4-carbonitrile (CAS 343372-95-2)
- Methyl 4-(1H-pyrazol-1-ylmethyl)benzoate (CAS 397328-86-8)
- Des-[Oct-γ-Glu-AEEA-AEEA]-Semaglutide (CAS CATO-C4X-2226112)
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