Finasteride Impurity 43 CAS 104214-61-1
| CAS No. | 104214-61-1 |
| Molecular Formula | C19H28N2O2 |
| Molecular Weight | 316.44 g/mol |
| 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 Finasteride Impurity 43.
Finasteride Impurity 43 (CAS 104214-61-1) is a certified pharmaceutical impurity reference standard with the molecular formula C19H28N2O2 and a molecular weight of 316.44 g/mol.
Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, Finasteride Impurity 43 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 316.44 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.
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 | C19H28N2O2 |
| Molecular Weight | 316.44 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | 97%+ |
| Storage | Store at 2-8°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 |
| Degree of Unsaturation (DBE) | 7.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1986 |
| Nitrogen Atoms | 2 |
Related Finasteride Standards
- Finasteride Impurity 14 (CAS 302-97-6)
- Finasteride Impurity 23 (CAS CATO-C4X-164523)
- Finasteride Impurity N89 (CAS 1180488-92-9)
- Finasteride Impurity 31 (CAS 1667725-37-2)
- Finasteride Impurity 34 (CAS 73711-89-4)
- Finasteride Impurity 36 (CAS CATO-C4X-164536)
- Finasteride Impurity N50 (CAS 10325-79-8)
- Finasteride Impurity 32 (CAS 51872-67-4)
Recommended Standards
- tert-Butyl rel-(3aR,5R,6aS)-5-(benzylamino)-3,3a,4,5,6,6a-hexahydro-1H-cyclopenta[c]pyrrole-2-carboxylate (CAS 863600-79-7)
- Gadobutrol impurity 178 (CAS 138147-50-9)
- tert-Butyl 7-methyl-2,3-dihydro-1H-spiro[isoquinoline-4,4'-piperidine]-1'-carboxylate (CAS 906369-89-9)
- Gadobutrol impurity 180 (CAS 198637-63-7)
- Posaconazole Impurity 101 (CAS CATO-C4X-1208101)
- Lifitegrast Impurity 145 (CAS CATO-C4X-2409145)
- Potassium Clavulanate Impurity 14 (CAS 92632-79-6)
- 2-(4-methyl-4H-1,2,4-triazol-3-yl)propan-1-amine dihydrochloride (CAS 1797160-58-7)
- 4-Pentyn-1-ol (CAS 5390-04-5)
- 4',6'-Bis(4-aminophenyl)-[1,1':3',1''-terphenyl]-4,4''-dicarbaldehyde (CAS 2583822-09-5)
- 2,3',4-Trimethyldiphenylmethane (CAS 721-54-0)
- Atogepant Impurity 72 (CAS CATO-C4X-328572)
- 7,8-Dihydroxyisoquinoline-3-carboxamide (CAS 146515-43-7)
- Tirzepatide Impurity 46 (CAS CATO-C4X-324046)
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