Donepezil Impurity 53 CAS 149874-81-7
| CAS No. | 149874-81-7 |
| Molecular Formula | C25H31NO3 |
| Molecular Weight | 393.52 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Donepezil Impurity 53 (CAS 149874-81-7, C25H31NO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, Donepezil Impurity 53 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 393.52 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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), Donepezil Impurity 53 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 | C25H31NO3 |
| Molecular Weight | 393.52 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 11.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1999 |
| Nitrogen Atoms | 1 |
Related Donepezil Standards
- Donepezil Impurity 51 (CAS CATO-C4X-103951)
- Donepezil Impurity 74 (CAS CATO-C4X-103974)
- Donepezil Impurity 15 (CAS 1023500-88-0)
- Donepezil Impurity 31 (CAS 2097683-67-3)
- Donepezil EP impurity C (CAS 2452407-76-8)
- Donepezil Impurity 7 (CAS 120013-84-5)
- Donepezil Impurity 40 (CAS 923571-16-8)
- Donepezil D7 (CAS 1215071-00-3)
Recommended Standards
- N-(4-(N-(2-(Pyrrolidin-1-yl)-2-(thiophen-3-yl)ethyl)sulfamoyl)phenyl)acetamide (CAS 946356-93-0)
- Nalmefene Impurity 21 (CAS CATO-C4X-126821)
- N-(2-((4-Phenylpiperazin-1-yl)sulfonyl)ethyl)-2-(thiophen-2-yl)acetamide (CAS 897621-83-9)
- Nalmefene Impurity 6 (CAS CATO-C4X-12686)
- Cariprazine Impurity 25 (CAS CATO-C4X-240825)
- Vortioxetine Impurity 88 (CAS 103-19-5)
- Omadacycline impurity 18 (CAS CATO-C4X-285718)
- 4-(Piperidin-4-yl)benzonitrile hydrochloride (CAS 162997-34-4)
- 2,4,5-Trifluorobenzamide (CAS 98349-23-6)
- rel-(2R,3S)-3-Methyloxirane-2-carboxylic acid (CAS 96150-05-9)
- 4-(Chlorosulfonyl)-5,6,7,8-tetrahydronaphthalene-2-carboxylic acid (CAS 926202-14-4)
- 6-(Dimethylamino)nicotinimidamide (CAS 1016873-23-6)
- Methyl 4-(2-amino-4-chlorophenoxy)benzoate (CAS 941116-96-7)
- Anti-Inflammatory Peptide 2 (CAS 118850-72-9)
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