Amlodipine Impurity N5 CAS 107812-86-2
| CAS No. | 107812-86-2 |
| Molecular Formula | C18H19Cl2NO4 |
| Molecular Weight | 384.25 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
As a process- or degradation-related impurity, Amlodipine Impurity N5 (CAS 107812-86-2, C18H19Cl2NO4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Amlodipine Impurity N5 (C18H19Cl2NO4) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 9.0, corresponding to approximately 9 ring(s) or double-bond equivalent(s). With a molecular weight of 384.25 g/mol, it falls into the moderately-high-molecular-weight range. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
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.
Physical & Chemical Properties
| Molecular Formula | C18H19Cl2NO4 |
| Molecular Weight | 384.25 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| 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.) | 1987 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
Related Amlodipine Standards
- Amlodipine Impurity 52 (CAS CATO-C4X-109552)
- Amlodipine Impurity 18 (CAS 1809326-44-0)
- Amlodipine Impurity 19 (CAS CATO-C4X-109519)
- Amlodipine Impurity 77 (CAS 2802443-91-8)
- Amlodipine Impurity 75 (CAS 113994-44-8)
- Amlodipine Impurity N1 (CAS 194472-27-0)
- Amlodipine Impurity 30 (CAS 496024-43-2)
- Amlodipine Impurity 60 (CAS 949155-13-9)
Recommended Standards
- Felodipine (CAS 72509-76-3)
- 8-(2,4-Dichlorobenzoyl)-3-propyl-1,3,8-triazaspiro[4.5]decane-2,4-dione (CAS 1021210-54-7)
- 4-(4-Bromophenyl)-1-tert-butoxycarbonyl-piperidine-4-carboxylic acid (CAS 1076197-05-1)
- Felodipine Impurity 31 (CAS CATO-C4X-109431)
- Atomoxetine Impurity 30 (CAS CATO-C4X-155030)
- Levonorgestrel Impurity 42 (CAS 62298-52-6)
- Olprinone impurity 35 (CAS 136117-77-6)
- 4-(((5-(4-Chlorophenyl)-4-(p-tolyl)-4H-1,2,4-triazol-3-yl)thio)methyl)benzoic acid (CAS 443741-75-1)
- Tinidazole Impurity 18 (CAS 159790-76-8)
- 2-(4-(Bis(2-iodoethyl)amino)benzylidene)malononitrile (CAS 92199-03-6)
- 2-(4-Chlorophenyl)benzothiazole (CAS 6265-91-4)
- 2-Amino-2-(2-fluoro-5-nitrophenyl)acetic Acid (CAS 1270310-65-0)
- Bromo-PEG2-C2-Boc (CAS 1381861-91-1)
- Peptide Impurity 34 (CAS 21282-09-7)
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