Ketorolac EP Impurity H CAS 80965-09-9
| CAS No. | 80965-09-9 |
| Molecular Formula | C16H15NO3 |
| Molecular Weight | 269.30 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a certified reference material (CRM), Ketorolac EP Impurity H 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.
Ketorolac EP Impurity H (CAS 80965-09-9) is a certified pharmaceutical impurity reference standard with the molecular formula C16H15NO3 and a molecular weight of 269.30 g/mol.
The molecular framework of Ketorolac EP Impurity H (C16H15NO3) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, 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 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.
Physical & Chemical Properties
| Molecular Formula | C16H15NO3 |
| Molecular Weight | 269.30 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 chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; 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.) | 1980 |
| Nitrogen Atoms | 1 |
Related Ketorolac Standards
- Ketorolac Impurity 22 (CAS CATO-C4X-166922)
- Ketorolac Impurity 26 (CAS 111930-01-9)
- Ketorolac Impurity 57 (CAS CATO-C4X-166957)
- Ketorolac Impurity 58 (CAS CATO-C4X-166958)
- Ketorolac Impurity 51 (CAS 111122-84-0)
- Ketorolac Impurity 52 (CAS 147088-89-9)
- Ketorolac-d5 (CAS 1215767-66-0)
- rac Ketorolac-d4 (CAS 1216451-53-4)
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