Levocetirizine Impurity 48 CAS CATO-C4X-108348
| CAS No. | CATO-C4X-108348 |
| Molecular Formula | C25H33ClN2O4 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Levocetirizine Impurity 48.
CATO supplies Levocetirizine Impurity 48 (CAS CATO-C4X-108348), a pharmacopoeial impurity reference standard (molecular formula C25H33ClN2O4HCl, MW 497.46 g/mol) used for the identification and quantification of trace impurities in APIs.
Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Levocetirizine Impurity 48 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 497.46 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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 | C25H33ClN2O4 2*HCl |
| Molecular Weight | 497.46 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 Levocetirizine Standards
- Levocetirizine Impurity 50 (CAS 1074-42-6)
- Levocetirizine Impurity 5 (CAS 109036-15-9)
- Levocetirizine Impurity 43 (CAS 1116338-10-3)
- Levocetirizine Impurity 45 (CAS 1150310-68-1)
- Levocetirizine Dihydrochloride - Impurity H (Hydrochloride Salt) (CAS 1177093-13-8)
- Levocetirizine Impurity 24 (CAS 1232460-29-5)
- Levocetirizine Impurity 80 (CAS 1232460-31-9)
- Levocetirizine Impurity 17 (CAS 126517-38-2)
Recommended Standards
- Repaglinide EP Impurity B (CAS 99469-99-5)
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- Ethyl 8-(3-bromophenyl)-8-oxooctanoate (CAS 898792-73-9)
- Lansoprazole Impurity 26 (CAS CATO-C4X-111326)
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- 3-Bromo-4-chloro-6-methyl-1H-pyrazolo[3,4-d]pyrimidine (CAS 1276056-80-4)
- Calcium-Like Peptide 3 (CAS 261969-05-5)
Why CATO?
- ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
- 130,000+ catalog items in stock, COA supplied with every batch
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- Technical support: +86 18665070610 / Nicole.chen@cato-chem.com