Donepezil Impurity 69 CAS CATO-C4X-103969
| CAS No. | CATO-C4X-103969 |
| Molecular Formula | C24H29NO4 |
| Molecular Weight | N/A |
| 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 Donepezil Impurity 69.
As a process- or degradation-related impurity, Donepezil Impurity 69 (CAS CATO-C4X-103969, C24H29NO4HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C24H29NO4HCl, Donepezil Impurity 69 contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 431.96 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.
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 | C24H29NO4 HCl |
| Molecular Weight | 431.96 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store at room temperature, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| 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) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
Related Donepezil Standards
- Donepezil Impurity 15 (CAS 1023500-88-0)
- Donepezil Impurity 44 (CAS 1026443-48-0)
- Donepezil Impurity 46 (CAS 1034439-43-4)
- Donepezil-d5 (CAS 1128086-25-8)
- Donepezil Impurity 55 (CAS 1189443-74-0 (free base))
- Donepezil Related Compound A HCl (CAS 120011-69-0)
- Donepezil Hydrochloride (CAS 120011-70-3)
- Donepezil Impurity 25 (CAS 120012-04-6)
Recommended Standards
- Fluvoxamine EP Impurity J (CAS 1217241-15-0)
- Cefuroxime Axetil Impurity 7 (CAS 59176-08-8)
- Trazodone Impurity 7 (CAS 53818-10-3)
- (R)-2,3-Diaminopropan-1-ol (CAS 87638-26-4)
- 1-Heptadecyl-1H-imidazole (CAS 25268-79-5)
- n-((1,2,3-Thiadiazol-4-yl)methyl)-2,5-difluoroaniline (CAS 1156892-87-3)
- H-Ser-Glu-OH (CAS 6403-16-3)
- 4,4'-Bipyridinium, 1,1''-[1,4-phenylenebis(methylene)]bis-, dibromide (CAS 106867-97-4)
- 6-Bromo-2-(methylsulfonyl)-1,2,3,4-tetrahydroisoquinoline (CAS 1046816-12-9)
- Neuropeptide W-23 (human) (CAS 383415-79-0)
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