Fingolimod Hydrochloride EP Impurity B CAS 162361-44-6
| CAS No. | 162361-44-6 |
| Molecular Formula | C18H31NO2 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Fingolimod Hydrochloride EP Impurity B is closely related to an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
As a process- or degradation-related impurity, Fingolimod Hydrochloride EP Impurity B (CAS 162361-44-6, C18H31NO2HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Fingolimod Hydrochloride EP Impurity B (C18H31NO2HCl) is characterized by an amide group, a carboxylic acid 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 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 | C18H31NO2 HCl |
| Molecular Weight | 329.91 g/mol |
| Appearance | White to pale yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 3.0 |
| UV Absorption | UV-absorbing |
| CAS Registry Year (est.) | 2003 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
Related Fingolimod Standards
- Fingolimod Impurity 18 (CAS 1068-90-2)
- Fingolimod EP Impurity A (CAS 1201794-93-5)
- Fingolimod Palmitate Amide (CAS 1242271-26-6)
- Fingolimod Stearate Amide (CAS 1242271-27-7)
- Fingolimod Impurity 41 (CAS 125574-44-9)
- Fingolimod-D4 Hydrochloride (CAS 1346604-90-7)
- Fingolimod-d4 (CAS 1346747-38-3)
- Fingolimod Impurity 16 (CAS 1404433-87-9)
Recommended Standards
- Clopidogrel Impurity 31 (CAS 19995-38-1)
- Minodronic Impurity 34 (CAS 164733-64-6)
- Brivaracetam Impurity 151 (CAS CATO-C4X-2007151)
- Sodium 2-methyl-2-(pyridin-2-yl)propanoate (CAS 1039547-74-4)
- 3-Amino-4-chloro-N-(2-chlorophenyl)benzenesulfonamide (CAS 325724-69-4)
- (3S,4S)-4-aminotetrahydro-2H-pyran-3-carboxylic acid hydrochloride (CAS 2306249-66-9)
- D-(+)-Galactose (CAS 59-23-4)
- N'-tert-Butyl-N'-phenylbenzohydrazide (CAS 866153-75-5)
- 2-Chloro-5-(4-chlorophenyl)nicotinonitrile (CAS 35982-99-1)
- Acetyl Tetrapeptide-5 (CAS 820959-17-9)
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