Duloxetine Impurity 31 CAS 940291-11-2
| CAS No. | 940291-11-2 |
| Molecular Formula | C18H19NOS |
| Molecular Weight | 297.41 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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 process- or degradation-related impurity, Duloxetine Impurity 31 (CAS 940291-11-2, C18H19NOS) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Duloxetine Impurity 31 (C18H19NOS) is characterized by a steroid core, an amide group, sulfur-containing functionality, a hydroxyl group, an ether linkage. 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 high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.
As a certified reference material (CRM), Duloxetine Impurity 31 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 |
| Molecular Weight | 297.41 g/mol |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1987 |
| Nitrogen Atoms | 1 |
| Sulfur Atoms | 1 |
Related Duloxetine Standards
- Duloxetine EP Impurity A (CAS 116539-60-7)
- Duloxetine Impurity C (In-house) (CAS 116817-13-1)
- Rac-Duloxetine EP Impurity F (CAS 116817-27-7)
- Duloxetine EP Impurity C (CAS 949095-98-1)
- Duloxetine EP Impurity F (CAS 959392-22-4)
- Duloxetine EP Impurity E (CAS 1033803-59-6)
- Duloxetine 2-Naphthalenol Impurity (CAS 1346599-09-4)
- Duloxetine (CAS 116539-59-4)
Recommended Standards
- Tolindate (CAS 27877-51-6)
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- Cariprazine Impurity 68 (CAS CATO-C4X-240868)
- Bumetanide Impurity 34 (CAS CATO-C4X-198634)
- Trilaciclib Impurity 2 (CAS CATO-C4X-30442)
- Duloxetine Impurity 34 (CAS CATO-C4X-133634)
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- 2-(4-chlorophenyl)-4-methylpentanoic acid (CAS 33127-05-8)
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- 3',5'-Dimethyl-[1,1'-biphenyl]-4-amine (CAS 444143-44-6)
- 3-Chloro-N-(2,4-difluorobenzyl)-2,2-dimethylpropanamide (CAS 134672-77-8)
- tert-Butyl (4-ethynylthiazol-2-yl)carbamate (CAS 815610-14-1)
- Semaglutide impurity 98 (CAS CATO-C4X-222698)
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