Cetirizine Impurity 35 CAS CATO-C4X-158235
| CAS No. | CATO-C4X-158235 |
| Molecular Formula | C19H22N2O2 |
| Molecular Weight | 310.39 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Cetirizine Impurity 35 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
As a process- or degradation-related impurity, Cetirizine Impurity 35 (CAS CATO-C4X-158235, C19H22N2O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Cetirizine Impurity 35 (C19H22N2O2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 10.0, corresponding to approximately 10 ring(s) or double-bond equivalent(s). With a molecular weight of 310.39 g/mol, it falls into the moderately-high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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.
As a certified reference material (CRM), Cetirizine Impurity 35 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
Physical & Chemical Properties
| Molecular Formula | C19H22N2O2 |
| Molecular Weight | 310.39 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | 97%+ |
| Storage | Store at 2-8°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 |
| Degree of Unsaturation (DBE) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 2 |
Related Cetirizine Standards
- Cetirizine Impurity 36 (CAS CATO-C4X-158236)
- Cetirizine Impurity Y (CAS 34605-45-3)
- Cetirizine EP Impurity G (CAS 109806-71-5)
- Cetirizine Impurity 26 (CAS CATO-C4X-158226)
- Cetirizine EP Impurity A (CAS 303-26-4)
- Cetirizine impurity N1 (CAS 58023-19-1)
- Cetirizine Impurity 22 (CAS 13391-38-3)
- Cetirizine Dihydrochloride EP Impurity B (CAS 942193-17-1)
Recommended Standards
- Clotrimazole EP Impurity F (CAS 15469-97-3)
- 2,2 '- [Carbonyl bis (thio)] diethylsulfonic acid (CAS 1110813-35-8)
- Bifonazole EP Impurity B (CAS 91679-37-7)
- Ritonavir Impurity 59 (CAS CATO-C4X-175159)
- Flomoxef Impurity N2 (CAS 91177-27-4)
- Trientine Impurity 4 (CAS 281676-73-1)
- Rosuvastatin Impurity 68 (CAS CATO-C4X-116968)
- 2-[5-Methoxy-4-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)-2-pyridyl]-N-methyl-acetamide (CAS 1448871-33-7)
- N-(4-fluoro-3-nitrophenyl)-2-(pyrrolidin-1-yl)acetamide (CAS 952182-62-6)
- 2-FLUORO-4-FORMYLBENZENEBORONIC ACID 2-FLUORO-4-FORMYLPHENYLBORONIC ACID 871126-22-6 B-(2-FLUORO-4-FORMYLPHENYL)-BORONIC ACID BC001245 BORONIC ACID, B-(2-FLUORO-4-FORMYLPHENYL)- (CAS 871126-22-6)
- 8-Chloroimidazo[1,2-α]pyrazine (CAS 69214-33-1)
- 3-Chloro-4-hydrazinyl-5-(pyrrolidin-1-ylsulfonyl)pyridine (CAS 1352525-98-4)
- 4,5-Dimethyl-1,3,2-dioxathiolane 2-oxide (CAS 4440-90-8)
- Tirzepatide Impurity 59 (CAS CATO-C4X-324059)
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