Nortriptyline EP Impurity B HCl CAS 438-59-5
| CAS No. | 438-59-5 |
| Molecular Formula | C19H19N |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Nortriptyline EP Impurity B HCl (CAS 438-59-5) is a certified pharmaceutical impurity reference standard with the molecular formula C19H19NHCl and a molecular weight of 297.83 g/mol.
Nortriptyline EP Impurity B HCl (C19H19NHCl) contains a nitrogen-containing heterocyclic scaffold, a nitrile group, chlorine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility; 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 | C19H19N HCl |
| Molecular Weight | 297.83 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1957 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
Related Nortriptyline Standards
- Nortriptyline Impurity 23 (CAS 1154-08-1)
- Nortriptyline EP Impurity E-D3 HCl (CAS 1184983-42-3)
- Nortriptyline EP Impurity I (CAS 1210-34-0)
- Nortriptyline Impurity 21 (CAS 1562-52-3)
- Nortriptyline EP Impurity G (CAS 16234-88-1)
- Nortriptyline Impurity 1 HCl (CAS 1750-07-8)
- Nortriptyline EP Impurity H (CAS 24755-73-5)
- Nortriptyline EP Impurity B (CAS 303-50-4)
Recommended Standards
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- ACTH (3-24) (human, bovine, rat) (CAS 1036763-00-4)
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- 2-(Difluoromethyl)-5-iodo-3-methoxypyridine-4-sulfonyl chloride (CAS 1805533-73-6)
- 3,4,5,6-Tetrahydro-2h-cyclopenta[d]thiazol-2-imine hydrochloride (CAS 82514-58-7)
- 4-((6-Amino-3-methyl-2,4-dioxo-1,2,3,4-tetrahydropyrimidin-5-yl)amino)-4-oxobutanoic acid (CAS 169234-54-2)
- 2-Methoxy-4-nitrophenyl isothiocyanate (CAS 190774-55-1)
- C-Type Natriuretic Peptide (32-53) (human, porcine, rat) (CAS 127869-51-6)
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