Donepezil EP impurity B CAS 2107-69-9
| CAS No. | 2107-69-9 |
| Molecular Formula | C11H12O3 |
| Molecular Weight | 192.21 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Donepezil EP impurity B is closely related to a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
As a process- or degradation-related impurity, Donepezil EP impurity B (CAS 2107-69-9, C11H12O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system, Donepezil EP impurity B is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 192.21 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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 | C11H12O3 |
| Molecular Weight | 192.21 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1957 |
Related Donepezil Standards
- Donepezil Intermediate 21 (CAS 6443-72-7)
- Donepezil Aldehyde Impurity (CAS 22065-85-6)
- Donepezil Impurity 16 (CAS 36517-91-6)
- Donepezil Impurity 17 (CAS 127399-78-4)
- Donepezil Impurity 18 (CAS 90843-62-2)
- Donepezil Impurity 14 (CAS 148517-82-2)
- Donepezil Impurity 60 (CAS 7216-42-4)
- Donepezil Impurity 44 (CAS 1026443-48-0)
Recommended Standards
- Milnacipran impurity 37 (CAS 96847-51-7)
- Edaravone Impurity 10 (CAS 710307-89-4)
- Milnacipran impurity 34 (CAS CATO-C4X-103334)
- Edaravone Impurity 11 (CAS CATO-C4X-106211)
- Arbidol Impurity 2 (CAS 131707-24-9)
- Lifitegrast Impurity 126 (CAS CATO-C4X-2409126)
- Cefradine EP Impurity B (CAS 26774-88-9)
- 1-(Phenylsulfonyl)-1H-indole-3-carbaldehyde (CAS 80360-20-9)
- 7-Methyl-9-nitro-4,5-dihydro-1,4-benzoxazepin-3(2H)-one (CAS 697234-10-9)
- n-(Butan-2-yl)-2-chloropropanamide (CAS 87603-53-0)
- Niraparib Impurity N10 HCl (CAS 2409590-07-2)
- 4-(Tert-butoxycarbonyl)-4,5,6,7-tetrahydro-[1,2,3]triazolo[1,5-a]pyrimidine-3-carboxylic acid (CAS 2172547-55-4)
- 2,3-Diamino-6-bromophenol (CAS 1803592-72-4)
- Valosin Peptide (VQY), porcine (CAS 99510-37-9)
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