Amlodipine Impurity 83 CAS CATO-C4X-109583
| CAS No. | CATO-C4X-109583 |
| Molecular Formula | C20H22ClNO5 |
| Molecular Weight | 391.85 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 Amlodipine Impurity 83.
Amlodipine Impurity 83 (CAS CATO-C4X-109583) is a certified pharmaceutical impurity reference standard with the molecular formula C20H22ClNO5 and a molecular weight of 391.85 g/mol.
Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Amlodipine Impurity 83 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 391.85 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.
As a certified reference material (CRM), Amlodipine Impurity 83 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 | C20H22ClNO5 |
| Molecular Weight | 391.85 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | >95% |
| Storage | Store at 2-8°C, 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) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
Related Amlodipine Standards
- Amlodipine Impurity N1 (CAS 194472-27-0)
- Amlodipine Impurity 30 (CAS 496024-43-2)
- Amlodipine Impurity 60 (CAS 949155-13-9)
- Amlodipine Impurity 78 (CAS CATO-C4X-109578)
- Amlodipine Impurity 76 (CAS CATO-C4X-109576)
- Amlodipine Impurity N20 (CAS 2170104-02-4)
- Amlodipine Impurity 77 (CAS 2802443-91-8)
- Amlodipine Impurity 38 (CAS 113994-37-9)
Recommended Standards
- Avanafil Impurity 5 (CAS 372117-54-9)
- Avanafil Impurity 89 (CAS 2250243-36-6)
- Ketorolac Impurity 56 (CAS CATO-C4X-166956)
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- Hexanedioic acid, polymer with 1,2-ethanediol and 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (CAS 25214-75-9)
- Angiotensin II Antipeptide (CAS 121379-63-3)
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