Felodipine EP Impurity A HCl CAS CATO-C4X-109426
| CAS No. | CATO-C4X-109426 |
| Molecular Formula | C18H17Cl2NO4 |
| 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 Felodipine EP Impurity A HCl.
As a process- or degradation-related impurity, Felodipine EP Impurity A HCl (CAS CATO-C4X-109426, C18H17Cl2NO4HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Felodipine EP Impurity A HCl (C18H17Cl2NO4HCl) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. Halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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 | C18H17Cl2NO4 HCl |
| Molecular Weight | 418.69 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| 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) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
Related Felodipine Standards
- S-(-)-Felodipine (CAS 105618-03-9)
- rac Felodipine-d3 (CAS 1189970-31-7)
- R-(+)-Felodipine (CAS 119945-59-4)
- (±)-Felodipine-d3 (CAS 1219795-30-8)
- Felodipine-d5 (CAS 1242281-38-4)
- Felodipine Impurity 11 (CAS 150131-21-8)
- Felodipine Impurity 15 (CAS 21962-45-8)
- Felodipine Impurity 25(E/Z Mixture) (CAS 313967-20-3)
Recommended Standards
- Levothyroxine Impurity 25 (CAS CATO-C4X-167825)
- Ambroxol Impurity 98 (CAS CATO-C4X-108598)
- Sitagliptin Impurity 54 (CAS 1608491-98-0（free base）)
- 10494-80-1 8074AC C8H17NO3 Ethyl 3-[(3-hydroxypropyl)amino]propanoate (CAS 10494-80-1)
- 4-Methylphenoxyacetonitrile (CAS 33901-44-9)
- 3-(2,5-Dimethylfuran-3-yl)-1h-pyrazol-5-amine (CAS 1028843-17-5)
- 1-ethyl-1H-benzimidazol-5-amine hydrochloride 62874-34-4 R9072 (CAS 62874-34-4)
- Ethyl 2-(1,2,3,4-tetrahydroisoquinolin-7-yl)acetate hydrochloride (CAS 1956355-06-8)
- 1-(4-Bromo-2-fluorophenyl)butan-2-one (CAS 1251035-56-9)
- Fibrinogen Related Peptide (CAS 80755-86-8)
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