Duloxetine EP Impurity A CAS 910138-96-4
| CAS No. | 910138-96-4 |
| Molecular Formula | C18H19NOS |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Duloxetine EP Impurity A (CAS 910138-96-4) is a certified pharmaceutical impurity reference standard with the molecular formula C18H19NOSHCl and a molecular weight of 333.87 g/mol.
The molecular framework of Duloxetine EP Impurity A (C18H19NOSHCl) is characterized by a steroid core, an amide group, sulfur-containing functionality, 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. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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), Duloxetine EP Impurity A 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 | C18H19NOS HCl |
| Molecular Weight | 333.87 g/mol |
| 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.) | 1987 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
| Sulfur Atoms | 1 |
Related Duloxetine Standards
- Duloxetine EP Impurity E HCl (CAS 1033719-36-6)
- Duloxetine EP Impurity E (CAS 1033803-59-6)
- Duloxetine Impurity 55 (CAS 1045348-04-6)
- Duloxetine Impurity 9 (CAS 110-14-5)
- rac-Duloxetine EP Impurity F HCl (CAS 1104890-90-5)
- Duloxetine EP Impurity B (CAS 116539-55-0)
- Duloxetine Impurity (CAS 116539-57-2)
- Duloxetine (CAS 116539-59-4)
Recommended Standards
- Vortioxetine Impurity 118 (CAS 94041-16-4)
- Tirofiban Impurity 27 (CAS 2374-69-8)
- Dopamine Impurity 12 HCl (CAS 101089-44-5)
- 2-Ethyl-2-(((3,5,5-trimethylhexanoyl)oxy)methyl)propane-1,3-diyl bis(3,5,5-trimethylhexanoate) (CAS 65870-94-2)
- Nicorandil Impurity 50 (CAS CATO-C4X-190750)
- 6-fluoroquinolin-2-amine (CAS 791626-57-8)
- chloromethanesulfonic acid (CAS 40104-07-2)
- N-(3-Bromophenyl)-2-(pyridin-3-yl)acetamide (CAS 1283114-92-0)
- 2-Amino-N-(3-chloro-2-methoxyphenyl)benzamide (CAS 725704-79-0)
- Peptide 74 (H-8545.0500) (CAS 132116-39-3)
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