Doxepin EP Impurity C HCl CAS 4504-96-5
| CAS No. | 4504-96-5 |
| Molecular Formula | C18H19NO |
| 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 Doxepin EP Impurity C HCl.
As a process- or degradation-related impurity, Doxepin EP Impurity C HCl (CAS 4504-96-5, C18H19NOHCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Doxepin EP Impurity C HCl (C18H19NOHCl) 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 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.
As a certified reference material (CRM), Doxepin EP Impurity C HCl meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
Physical & Chemical Properties
| Molecular Formula | C18H19NO HCl |
| Molecular Weight | 301.81 g/mol |
| Appearance | Pale yellow to 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 |
| Degree of Unsaturation (DBE) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1958 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
Related Doxepin Standards
- Doxepin EP Imp C(Desmethyldoxepine)(USP (CAS 1225-56-5)
- Doxepin Hydrochloride (CAS 1229-29-4)
- Doxepin Impurity 2 (CAS 131523-93-8)
- Doxepin-D (CAS 138387-16-3)
- Doxepin Impurity 7 (CAS 21324-99-2)
- Doxepin impurity 17 (CAS 22684-91-9)
- Doxepin EP Impurity D HCl ((Z)-Doxepin HCl) (CAS 25127-31-5)
- Doxepin EP Impurity C HCl(Mixture of Z and E Isomers) (CAS 2887-91-4)
Recommended Standards
- Butenafine Impurity 11 (CAS 110951-99-0)
- Peramivir Impurity 13 (CAS 2758048-73-4)
- Bromhexine Impurity 9 (CAS 63471-29-4)
- 1,1-Di-tert-butoxy-N,N-dimethylmethylamine 1,1-Di-tert-butoxytrimethylamine 36805-97-7 N,N-Dimethylformamide di-tert-butyl acetal (CAS 36805-97-7)
- 2-(Difluoromethyl)-5-hydroxy-3-iodopyridine-6-acetonitrile (CAS 1807065-88-8)
- 3-Amino-1-(difluoromethyl)cyclobutan-1-ol (CAS 1423034-51-8)
- Methyl 2-Methyloxazole-5-acetate (CAS 1276083-60-3)
- 4-Amino-1-isopropylpyridin-2(1h)-one (CAS 1439902-59-6)
- 3-(2-Hydroxyethoxy)phenylboronic acid (CAS 2032409-49-5)
- Semaglutide impurity 55 (CAS CATO-C4X-222655)
Why CATO?
- ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
- 130,000+ catalog items in stock, COA supplied with every batch
- Worldwide shipping with full export documentation (HS code guidance available)
- Technical support: +86 18665070610 / Nicole.chen@cato-chem.com