Sivelestat Impurity 14 CAS CATO-C4X-212316
| CAS No. | CATO-C4X-212316 |
| Molecular Formula | C18H19N3O4 |
| Molecular Weight | 341.36 g/mol |
| 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 Sivelestat Impurity 14.
As a process- or degradation-related impurity, Sivelestat Impurity 14 (CAS CATO-C4X-212316, C18H19N3O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Sivelestat Impurity 14 (C18H19N3O4) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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 | C18H19N3O4 |
| Molecular Weight | 341.36 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| 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 |
| Degree of Unsaturation (DBE) | 11.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 3 |
Related Sivelestat Standards
- Sivelestat Impurity 34 (CAS CATO-C4X-212334)
- Sivelestat sodium Impurity 3 (CAS 155023-59-9)
- Sivelestat Impurity 8 (CAS CATO-C4X-21238)
- Sivelestat Impurity 11 (CAS CATO-C4X-212311)
- Sivelestat Impurity 25 (CAS CATO-C4X-212325)
- Sivelestat sodium Impurity 4 (CAS 188114-98-9)
- Sivelestat sodium impurity 22 (CAS 1655497-02-1)
- Sivelestat sodium impurity 46 (CAS CATO-C4X-212346)
Recommended Standards
- Norepinephrine Impurity 125 (CAS CATO-C4X-1514125)
- Tranilast impurity 5 (CAS 697235-52-2)
- Naloxone Impurity 23 (CAS CATO-C4X-149323)
- Belumosudil Impurity 38 (CAS CATO-C4X-298838)
- Carbidopa Impurity 14 (CAS CATO-C4X-231014)
- Docetaxel Impurity 38 (CAS 196404-55-4)
- Apremilast Impurity 1 (CAS 608141-44-2)
- 1-(Triphenylsilyl)ethanol (CAS 18666-82-5)
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- Methyl 6-chloro-2-methyl-1H-indole-3-carboxylate (CAS 762288-09-5)
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- Methyl (E)-3-(3,4-dihydro-2H-pyrano[2,3-b]pyridin-6-yl)acrylate (CAS 1346451-50-0)
- Peptide 438 (CAS CATO-CPTD788438)
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