Desloratadine Impurity 31 CAS 109537-11-3
| CAS No. | 109537-11-3 |
| Molecular Formula | C22H23ClN2O2 |
| Molecular Weight | 382.88 g/mol |
| 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 Desloratadine Impurity 31.
As a process- or degradation-related impurity, Desloratadine Impurity 31 (CAS 109537-11-3, C22H23ClN2O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Desloratadine Impurity 31 (C22H23ClN2O2) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.
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 | C22H23ClN2O2 |
| Molecular Weight | 382.88 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| 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) | 12.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1988 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |
Related Desloratadine Standards
- Desloratadine Impurity 32 (CAS 1346605-16-0)
- Desloratadine Impurity 51 (CAS CATO-C4X-143051)
- Desloratadine Impurity 52 (CAS CATO-C4X-143052)
- Desloratadine Impurity 55 (CAS CATO-C4X-143055)
- Desloratadine Impurity 50 (CAS CATO-C4X-143050)
- Desloratadine Impurity 63 (CAS CATO-C4X-143063)
- Desloratadine Impurity 64 (CAS CATO-C4X-143064)
- Desloratadine Impurity 65 (CAS CATO-C4X-143065)
Recommended Standards
- Loratadine EP Impurity E (CAS 170727-59-0)
- Loratadine (CAS 79794-75-5)
- Loratadine EP Impurity 41 (CAS 169253-13-8)
- 5-(3-Chlorophenyl)-3-(naphthalen-2-yl)-1-phenyl-4,5-dihydro-1H-pyrazole (CAS 329779-78-4)
- Aztreonam impurity 70 (CAS CATO-C4X-152270)
- Posaconazole Impurity 102 (CAS CATO-C4X-1208102)
- Cefcapene Impurity 43 (CAS CATO-C4X-182443)
- 2-(2-Chloro-8-methylquinolin-3-yl)acetonitrile (CAS 1017329-57-5)
- 4-Bromo-1-((2-(trimethylsilyl)ethoxy)methyl)-1H-indole (CAS 604788-42-3)
- 2-(3-methoxyphenyl)pyridin-3-amine (CAS 886508-13-0)
- 5-N-phenylpyridine-2,5-diamine (CAS 79441-22-8)
- TQS, >98% (HPLC) (CAS 353483-92-8)
- 3-Allylcycloheptanone (CAS 77802-58-5)
- Neuropeptide S (human) (CAS 412938-67-1)
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