Sitagliptin Tablets EP Impurity FP-B CAS 2805078-75-3
| CAS No. | 2805078-75-3 |
| Molecular Formula | C16H13F6N5O2 |
| Molecular Weight | 421.30 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Sitagliptin Tablets EP Impurity FP-B (CAS 2805078-75-3) is a certified pharmaceutical impurity reference standard with the molecular formula C16H13F6N5O2 and a molecular weight of 421.30 g/mol.
Based on its molecular formula C16H13F6N5O2, Sitagliptin Tablets EP Impurity FP-B contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 421.30 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
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.
As a certified reference material (CRM), Sitagliptin Tablets EP Impurity FP-B 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 | C16H13F6N5O2 |
| Molecular Weight | 421.30 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >95% |
| 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) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2003 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 5 |
Related Sitagliptin Standards
- Sitagliptin impurity 112 (CAS CATO-C4X-1144112)
- Sitagliptin impurity 29 (CAS 2088771-61-1)
- Sitagliptin Impurity 88 (CAS CATO-C4X-114488)
- Sitagliptin Impurity 130 (CAS CATO-C4X-1144130)
- Sitagliptin Impurity 10 (CAS 1253056-01-7)
- Sitagliptin EP Impurity A (CAS 823817-55-6)
- Sitagliptin Impurity 116 (CAS 945261-50-7)
- Sitagliptin Impurity 156 (CAS 945261-49-4)
Recommended Standards
- 4-Bromo-1-methyl-2-phenyl-5-(tosylmethyl)-1,2-dihydro-3H-pyrazol-3-one (CAS 1023502-23-9)
- Vismodegib (CAS 879085-55-9)
- tert-Butyl 4-((4-amino-5-bromopyridin-3-yl)sulfonyl)piperazine-1-carboxylate (CAS 1352498-10-2)
- 6-Bromo-3-(4-tert-butylbenzenesulfonyl)-2H-chromen-2-one (CAS 865656-27-5)
- Macitentan impurity 29 (CAS CATO-C4X-117529)
- Venlafaxine impurity 01 (CAS 131801-69-9)
- Raltitrexed Impurity 50 (CAS CATO-C4X-138650)
- 2-Fluoro-4'-(trifluoromethyl)-[1,1'-biphenyl]-4-amine (CAS 856898-03-8)
- 3-[(3-bromophenyl)methyl]-5H,6H,7H,8H-[1,2,4]triazolo[4,3-a]pyrazine dihydrochloride (CAS 1798729-90-4)
- 5-((Benzo[d][1,3]dioxol-5-ylmethyl)amino)-5-oxopentanoic acid (CAS 438530-15-5)
- Dibenzepin (CAS 4498-32-2)
- 4,6-Bis(trifluoromethyl)pyrimidin-2-ol (CAS 193068-48-3)
- 2-(6-Acetyl-4-(methoxycarbonyl)pyridin-2-yl)acetic acid (CAS 1393542-88-5)
- Human IgE Pentapeptide HEPP (CAS 62087-72-3)
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