Cetirizine Impurity 46 HCl CAS CATO-C4X-108346
| CAS No. | CATO-C4X-108346 |
| Molecular Formula | C23H29ClN2O4 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Compared with other compounds in its class, the molecular weight of 469.40 g/mol gives Cetirizine Impurity 46 HCl distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
As a process- or degradation-related impurity, Cetirizine Impurity 46 HCl (CAS CATO-C4X-108346, C23H29ClN2O4HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Cetirizine Impurity 46 HCl is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 469.40 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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 | C23H29ClN2O4 HCl |
| Molecular Weight | 469.40 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >95% |
| 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) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |
Related Cetirizine Standards
- Cetirizine EP Impurity B (CAS 1000690-91-4)
- Cetirizine Impurity 10 (CAS 1016-78-0)
- rac Cetirizine N-Oxide (Mixture of Diastereomers) (CAS 1076199-80-8)
- Cetirizine USP Related Compound B (CAS 108983-83-1)
- Cetirizine EP Impurity G (CAS 109806-71-5)
- (R)-Cetirizine-d4 Dihydrochloride (CAS 1133210-23-7)
- Cetirizine Impurity N19 (CAS 113740-61-7)
- rac Cetirizine-d8 N-Oxide (CAS 1216444-13-1)
Recommended Standards
- Atorvastatin Impurity 140 (CAS CATO-C4X-1132140)
- Oseltamivir EP Impurity F formate（Mixture of Diastereomers） (CAS CATO-C4X-17206)
- Tolterodine Impurity 13 (CAS CATO-C4X-176713)
- Bilastine impurity 83 (CAS CATO-C4X-225383)
- N-(4-fluorophenyl)-N-(2-furylmethyl)amine hydrochloride (CAS 1170482-00-4)
- Bis(4-(trifluoromethyl)phenyl)phosphine oxide (CAS 15929-43-8)
- cis-Ethyl 5,5-difluoro-4,5,6,6a-tetrahydro-3aH-cyclopenta[d]isoxazole-3-carboxylate (CAS 1428077-58-0)
- 1-(tert-Butylamino)-3,3-dimethylbutan-2-one hydrochloride (CAS 59288-29-8)
- 2-(Pyridin-4-yl)acetaldehyde (CAS 878499-08-2)
- Semaglutide impurity 86 (CAS CATO-C4X-222686)
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