Lemborexant Impurity 61 CAS 528587-69-1
| CAS No. | 528587-69-1 |
| Molecular Formula | C11H9FO2 |
| Molecular Weight | 192.19 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Lemborexant Impurity 61 (CAS 528587-69-1, C11H9FO2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C11H9FO2, Lemborexant Impurity 61 contains a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, an aromatic ring system; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 192.19 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.
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 | C11H9FO2 |
| Molecular Weight | 192.19 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; 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.) | 1984 |
| Halogen Content | F-containing |
Related Lemborexant Standards
- Lemborexant impurity 4 (CAS 528587-70-4)
- Lemborexant Impurity 53 (CAS CATO-C4X-304253)
- Lemborexant Impurity 62 (CAS CATO-C4X-304262)
- Lemborexant Impurity 75 (CAS 2412536-16-2)
- Lemborexant Impurity 92 (CAS CATO-C4X-304292)
- Lemborexant Impurity 93 (CAS CATO-C4X-304293)
- Lemborexant impurity 3 (CAS 571189-49-6)
- Lemborexant Impurity 38 (CAS 1450904-98-9)
Recommended Standards
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- Ticlopidine EP Impurity C (CAS 89-97-4)
- Docusate Impurity (Z)-Mono-2-Ethylhexyl Maleate (CAS 7423-42-9)
- Parecoxib Impurity 56 (CAS CATO-C4X-159156)
- N-Glucuronide Carbamazepine (CAS 60342-79-2)
- 1-(2-aminophenyl)-2-methylpropan-1-ol (CAS 574754-03-3)
- Aripiprazole Related Compound B (CAS 889443-20-3)
- 2-Amino-4,5,6,7-tetrahydrobenzo[d]thiazole-6-carboxylic acid (CAS 134136-03-1)
- 7-Methyl-5,6,7,8-tetrahydroquinoline (CAS 71350-24-8)
- Fmoc-L-Ala-CHN2 (CAS 193954-23-3)
- Fibrinogen-Binding Inhibitor Peptide (CAS 89105-94-2)
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