Difelikefalin Impurity 100 CAS 1821319-30-5 (free base)
| CAS No. | 1821319-30-5 (free base) |
| Molecular Formula | C37H55N7O6 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
Difelikefalin Impurity 100 (CAS 1821319-30-5 (free base)) is a certified pharmaceutical impurity reference standard with the molecular formula C37H55N7O6HCl and a molecular weight of 730.35 g/mol.
The molecular framework of Difelikefalin Impurity 100 (C37H55N7O6HCl) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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.
Physical & Chemical Properties
| Molecular Formula | C37H55N7O6 3*HCl |
| Molecular Weight | 730.35 g/mol |
| 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) | 13.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 7 |
Related Difelikefalin Standards
- Difelikefalin Impurity 46 (CAS 1021171-64-1)
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Recommended Standards
- Meropenem Impurity 53 (CAS CATO-C4X-130953)
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- 2-[(3-aminophenyl)methyl]-2h,3h-[1,2,4]triazolo[4,3-a]pyridin-3-one (CAS 1016764-72-9)
- (2R,3R,4S,5R,6S)-2-(((tert-butyldiphenylsilyl)oxy)methyl)-6-(p-tolylthio)tetrahydro-2H-pyran-3,4,5-triyl triacetate (CAS 959793-42-1)
- Chlorogenic Acid-13C6 (CAS 1323443-06-6)
- (1-Methylindolin-3-yl)methanol (CAS 795275-62-6)
- (5-Phenylpyridin-3-yl)methanamine (CAS 103921-71-7)
- 4-(Difluoromethyl)-5-fluoro-3-methoxy-2-(trifluoromethyl)pyridine (CAS 1805564-43-5)
- Des-[Gly]31-Semaglutide(x TFA Salt) (CAS 873874-39-6(free base))
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