Amlodipine EP Impurity G CAS 43067-01-2
| CAS No. | 43067-01-2 |
| Molecular Formula | C17H18ClNO4 |
| Molecular Weight | 335.78 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 EP Impurity G.
Amlodipine EP Impurity G (CAS 43067-01-2) is a certified pharmaceutical impurity reference standard with the molecular formula C17H18ClNO4 and a molecular weight of 335.78 g/mol.
Based on its molecular formula C17H18ClNO4, Amlodipine EP Impurity G contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 335.78 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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 | C17H18ClNO4 |
| Molecular Weight | 335.78 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) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1969 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
Related Amlodipine Standards
- Amlodipine Besylate Impurity 47 (CAS 1621516-91-3)
- Amlodipine impurity 126 (CAS CATO-C4X-1095126)
- Amlodipine Impurity N4 (CAS 113994-36-8)
- Amlodipine Impurity N22 (CAS 39562-06-6)
- Amlodipine Impurity 48 (CAS CATO-C4X-109548)
- Amlodipine Impurity 156 (CAS CATO-C4X-1095156)
- Amlodipine Impurity 27 (CAS 88150-75-8)
- Amlodipine Impurity 77 (CAS 265136-65-0)
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- Cefoperazone Impurity 49 (CAS CATO-C4X-114949)
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- N-(2-(Cyclohexylmethyl)-6-hydroxyphenyl)methanesulfonamide (CAS 1243282-83-8)
- tert-Butyl 5-bromo-6-methyl-1H-indole-1-carboxylate (CAS 1072157-39-1)
- 5-Chloro-1-(4-methylbenzyl)-2-oxo-N-phenyl-1,2-dihydropyridine-3-carboxamide (CAS 400087-62-9)
- Lafutidine Impurity 2 (CAS 174583-84-7)
- (1-(3-Methoxypropyl)cyclohexyl)methanol (CAS 1430752-32-1)
- (3S,4S)-1-((benzyloxy)carbonyl)-4-((tert-butoxycarbonyl)amino)pyrrolidine-3-carboxylic acid (CAS 1375312-84-7)
- Tirzepatide Impurity 36 (CAS CATO-C4X-324036)
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