Repaglinide Impurity 10 CAS CATO-C4X-118610
| CAS No. | CATO-C4X-118610 |
| Molecular Formula | C13H17NO4 |
| Molecular Weight | 251.28 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a certified reference material (CRM), Repaglinide Impurity 10 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.
As a process- or degradation-related impurity, Repaglinide Impurity 10 (CAS CATO-C4X-118610, C13H17NO4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Repaglinide Impurity 10 (C13H17NO4) 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 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.
Physical & Chemical Properties
| Molecular Formula | C13H17NO4 |
| Molecular Weight | 251.28 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 1 |
Related Repaglinide Standards
- Repaglinide EP Impurity B (CAS 99469-99-5)
- Repaglinide Impurity 13 (CAS 332347-70-3)
- Repaglinide Impurity 2 (CAS 219921-93-4)
- Repaglinide EP Impurity C (CAS 147769-93-5)
- Repaglinide Impurity O (CAS 147770-03-4)
- Repaglinide EP Impurity A (CAS 220438-80-2)
- Repaglinide Impurity 14 (CAS 107362-46-9)
- Repaglinide Impurity 15 (CAS 88709-17-5)
Recommended Standards
- Amoxicillin EP Impurity H (CAS 205826-86-4)
- Valaciclovir Impurity 35 (CAS 21691-44-1)
- rac-Amoxicillin EP Impurity H (CAS 106644-43-3)
- Nitroso Perindopril EP impurity K (CAS CATO-C4X-125249)
- Dronedarone Impurity 73 (CAS 5337-04-2)
- Atracurium Impurity 52 (CAS CATO-C4X-185052)
- Oseltamivir Impurity 57 HCI (CAS CATO-C4X-1720248)
- tert-Butyl (2-formyl-4-methoxyphenyl)carbamate (CAS 1260670-85-6)
- 2,3-Difluorobenzyl bromide (CAS 113211-94-2)
- Lercanidipine Impurity 34 (CAS 28075-29-8)
- 1-Bromo-2-difluoromethylbenzene stabilized over potassium carbonate 2-(difluoromethyl)bromobenzene 1-bromo-2-(difluoromethyl)benzene 845866-82-2 (CAS 845866-82-2)
- (4-Sulfophenoxy)acetic acid (CAS 54736-68-4)
- (Bromofluoromethyl)benzene (CAS 17815-88-2)
- Peptide 442 (CAS CATO-CPTD788442)
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