Quetiapine EP Impurity V DiHCl CAS 2204369-14-0 (free base)
| CAS No. | 2204369-14-0 (free base) |
| Molecular Formula | C21H25N3O2 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
As a process- or degradation-related impurity, Quetiapine EP Impurity V DiHCl (CAS 2204369-14-0 (free base), C21H25N3O2HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Quetiapine EP Impurity V DiHCl is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 387.91 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.
Physical & Chemical Properties
| Molecular Formula | C21H25N3O2 2*HCl |
| Molecular Weight | 387.91 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) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 3 |
Related Quetiapine Standards
- Quetiapine Carboxylate Impurity (CAS 1011758-00-1)
- Quetiapine EP Impurity P (CAS 1011758-03-4)
- Quetiapine EP Impurity P Hemifumarate (CAS 1011758-03-4（free base）)
- Quetiapine Impurity 56 (CAS 1015-89-0)
- Quetiapine Impurity N3 (CAS 102893-57-2)
- Quetiapine-d8 HemifumarateDISCONTINUED. Please see Q510002. (CAS 1031703-36-2)
- Quetiapine EP Impurity H (CAS 1076199-40-0)
- Quetiapine (CAS 111974-69-7)
Recommended Standards
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- 1-(2-(2-Aminoethyl)morpholino)ethan-1-one hydrochloride (CAS 2243162-52-7)
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- Sitaxsentan (CAS 184036-34-8)
- Closantel Sodium (CAS 61438-64-0)
- 2-(3-((2-Oxopyrrolidin-1-yl)methyl)phenyl)acetonitrile (CAS 1306606-35-8)
- Liraglutide(5-31)TFA Salt (CAS CATO-C4X-19924)
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