Amlodipine Besylate EP Impurity D Fumarate CAS 2138811-33-1
| CAS No. | 2138811-33-1 |
| Molecular Formula | C20H23ClN2O5 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.
As a process- or degradation-related impurity, Amlodipine Besylate EP Impurity D Fumarate (CAS 2138811-33-1, C20H23ClN2O5C4H4O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Amlodipine Besylate EP Impurity D Fumarate (C20H23ClN2O5C4H4O4) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. It is notably hygroscopic, 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 aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
As a certified reference material (CRM), Amlodipine Besylate EP Impurity D Fumarate 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 | C20H23ClN2O5 C4H4O4 |
| Molecular Weight | 522.94 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | >95% |
| Storage | Store in a cool place (≤25°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; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 12.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1997 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |
Related Amlodipine Standards
- Amlodipine Impurity N32 (CAS 103094-30-0)
- (R)-Amlodipine (CAS 103129-81-3)
- Amlodipine (S)-Isomer (CAS 103129-82-4)
- Amlodipine Impurity N5 (CAS 107812-86-2)
- Amlodipine Impurity N2 (CAS 111429-90-4)
- Amlodipine Besylate (CAS 111470-99-6)
- Amlodipine Impurity N4 (CAS 113994-36-8)
- Amlodipine Impurity 38 (CAS 113994-37-9)
Recommended Standards
- Dapagliflozin Impurity 131 (CAS CATO-C4X-1138131)
- Luliconazole Impurity 4 (CAS CATO-C4X-28534)
- Drotaverin Impurity 78 (CAS CATO-C4X-243578)
- tert-Butyl (4-bromobenzo[d]oxazol-2-yl)carbamate (CAS 2680887-74-3)
- Vortioxetine Impurity 68 (CAS CATO-C4X-105668)
- 3-(4-aminophenyl)-4,5-dihydro-1H-1,2,4-triazol-5-one (CAS 62036-31-1)
- 6-Methyl-1H-pyrrolo[2,3-b]pyridin-5-ol (CAS 1000340-88-4)
- 6,7-Dihydro-4H-thieno[3,2-c]pyran-4-carboxylic acid (CAS 1428233-08-2)
- 3-Bromo-5-methoxypyridazine (CAS 1401081-54-6)
- Tirzepatide Impurity 12 (CAS CATO-C4X-324012)
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