Etodolac EP Impurity I CAS CATO-C4X-16403
| CAS No. | CATO-C4X-16403 |
| Molecular Formula | C27H32N2O3 |
| Molecular Weight | 432.55 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Etodolac EP Impurity I (CAS CATO-C4X-16403) is a certified pharmaceutical impurity reference standard with the molecular formula C27H32N2O3 and a molecular weight of 432.55 g/mol.
The molecular framework of Etodolac EP Impurity I (C27H32N2O3) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, 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), Etodolac EP Impurity I 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 | C27H32N2O3 |
| Molecular Weight | 432.55 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | ≥95% |
| Storage | Store in a cool place (≤25°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) | 13.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 2 |
Related Etodolac Standards
- (+/-) Etodolac Acyl--D-glucuronide (CAS 79541-43-8)
- Etodolac Impurity 1 (CAS CATO-C4X-16401)
- Etodolac Ethyl Ester (CAS 200880-23-5)
- Etodolac Impurity 2 (CAS 101901-06-8)
- Etodolac Impurity 3 (CAS 101901-07-9)
- Etodolac Impurity 1 (CAS 101901-08-0)
- Etodolac EP Impurity K (CAS 122188-02-7)
- Etodolac EP Impurity D (CAS 57917-63-2)
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