Levocetirizine Impurity 54 HCl CAS 942132-30-1
| CAS No. | 942132-30-1 |
| Molecular Formula | C19H21ClN2O2 |
| 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 54 HCl.
Levocetirizine Impurity 54 HCl (CAS 942132-30-1) is a certified pharmaceutical impurity reference standard with the molecular formula C19H21ClN2O2HCl and a molecular weight of 381.30 g/mol.
Levocetirizine Impurity 54 HCl (C19H21ClN2O2HCl) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
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 | C19H21ClN2O2 HCl |
| Molecular Weight | 381.30 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >95% |
| 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; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1987 |
| 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
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- Mirabegron Impurity 111 (CAS CATO-C4X-1032111)
- Cetirizine Dihydrochloride EP Impurity B (CAS 942193-17-1)
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- 2-[1-(difluoromethyl)-1H-imidazol-2-yl]ethan-1-amine dihydrochloride (CAS 2059976-22-4)
- Lemborexant Impurity 93 (CAS CATO-C4X-304293)
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