Tadalafil Impurity 158 CAS 1863191-32-5
| CAS No. | 1863191-32-5 |
| Molecular Formula | C23H21ClN2O5 |
| Molecular Weight | 440.88 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Tadalafil Impurity 158 (CAS 1863191-32-5) is a certified pharmaceutical impurity reference standard with the molecular formula C23H21ClN2O5 and a molecular weight of 440.88 g/mol.
The molecular framework of Tadalafil Impurity 158 (C23H21ClN2O5) is characterized by a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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 | C23H21ClN2O5 |
| Molecular Weight | 440.88 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| 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) | 14.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1995 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |
Related Tadalafil Standards
- Tadalafil Impurity 48 (CAS CATO-C4X-108748)
- Tadalafil Impurity 183 (CAS CATO-C4X-1087183)
- Tadalafil Impurity 54 (CAS 171596-32-0)
- Tadalafil Impurity 157 (CAS CATO-C4X-1087157)
- Tadalafil Impurity 177 (CAS CATO-C4X-1087177)
- Tadalafil Impurity 35 (CAS 2169996-11-4)
- Tadalafil Impurity 59 (CAS CATO-C4X-108759)
- Tadalafil Impurity 80 (CAS CATO-C4X-108780)
Recommended Standards
- N'-[(1E)-[2-(4-Chlorophenoxy)phenyl]methylidene]-3,4,5-trimethoxybenzohydrazide (CAS 477886-80-9)
- 2-([1,1'-Biphenyl]-4-yloxy)-1,4-diamino-7-chloroanthracene-9,10-dione (CAS 88605-36-1)
- Lenvatinib Impurity 179 (CAS CATO-C4X-1140179)
- 2-([1,1'-Biphenyl]-4-yloxy)-1,4-diamino-6-chloroanthracene-9,10-dione (CAS 88605-25-8)
- Fosaprepitant impurity 56（S,S,S） (CAS CATO-C4X-116856)
- Ixazomib Impurity 62 (CAS CATO-C4X-126762)
- Cefditoren Impurity 3 (CAS 145904-68-3)
- 2,2-Dimethyl-3-morpholinopropan-1-amine (CAS 90796-54-6)
- N1-(6-chloro-2-methoxyacridin-9-yl)-N4-(cyclopropylmethyl)-N4-methylbutane-1,4-diamine (CAS 1411646-09-7)
- 2-(pyrazin-2-yl)ethan-1-amine (CAS 5321-59-5)
- Bis-(3-fluoro-benzyl)-piperidin-2-ylmethyl-amine hydrochloride (CAS 1261230-23-2)
- Phenyl nicotinate (CAS 3468-53-9)
- Sodium 4-chloro-3-nitrobenzenesulfinate (CAS 80917-26-6)
- Custom peptides (CAS CATO-CPTD788509)
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