Enalapril Impurity 10 CAS 32315-10-9
| CAS No. | 32315-10-9 |
| Molecular Formula | C3Cl6O3 |
| Molecular Weight | 296.75 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Enalapril Impurity 10 is closely related to a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
As a process- or degradation-related impurity, Enalapril Impurity 10 (CAS 32315-10-9, C3Cl6O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Enalapril Impurity 10 (C3Cl6O3) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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 | C3Cl6O3 |
| Molecular Weight | 296.75 g/mol |
| Purity | 97%+ |
| Storage | Store in a cool place (≤25°C), keep sealed and dry, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO, water |
| Stability | Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 1.0 |
| CAS Registry Year (est.) | 1966 |
| Halogen Content | Cl-containing |
Related Enalapril Standards
- Enalapril Impurity 13 (CAS 84793-24-8)
- Enalapril-d3DISCONTINUED. Please see E555258 and E555252 (CAS 1356847-94-3)
- Enalapril EP Impurity G (CAS 460720-14-3)
- Enalapril EP Impurity B (CAS 82717-96-2)
- Enalapril Diketopiperazine Acid (R-Isomer) (CAS 219677-80-2)
- Enalapril Maleate Impurity 26 (CAS 115623-21-7)
- Enalapril Maleate Impurity 28 (CAS CATO-C4X-133428)
- Enalapril Impurity 14 (Bis(2-chloroethyl)-Butanedioate) (CAS 925-17-7)
Recommended Standards
- Amlodipine Impurity 134 (CAS CATO-C4X-1095134)
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- 1-(2-Chloro-9-methyl-6-morpholino-9H-purin-8-yl)-N-methylmethanamine (CAS 1929582-97-7)
- Posaconazole Impurity 262(R/S Mixture) (CAS CATO-C4X-1208262)
- Phenylbutyrate Impurity 6 (CAS 1292210-87-7)
- Amisulpride Impurity 67 (CAS CATO-C4X-104567)
- 3-Hydroxy-2,3-dimethylbutan-2-yl hydrogen (5-(1H-pyrrol-1-yl)furan-2-yl)boronate (CAS 2223031-84-1)
- 6-Fluoro-2-(1H-pyrrol-1-yl)benzo[d]thiazole-4-carboxylic acid (CAS 1322604-98-7)
- 4-(2,4-Difluorophenoxy)-3-fluoroaniline (CAS 946785-83-7)
- 6-Bromo-4-hydroxy-2-trifluoromethylquinoline (CAS 1701-22-0)
- 3-(Cyclohexyl(methyl)amino)quinoxalin-2(1H)-one (CAS 731815-83-1)
- 1-[3-(trifluoromethyl)phenyl]cyclohexan-1-amine hydrochloride (CAS 125802-22-4)
- Peptide 434 (CAS CATO-CPTD788434)
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