Repaglinide EP Impurity A CAS 220438-80-2
| CAS No. | 220438-80-2 |
| Molecular Formula | C11H12O5 |
| Molecular Weight | 224.21 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Repaglinide EP Impurity A is closely related to a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
CATO supplies Repaglinide EP Impurity A (CAS 220438-80-2), a pharmacopoeial impurity reference standard (molecular formula C11H12O5, MW 224.21 g/mol) used for the identification and quantification of trace impurities in APIs.
Repaglinide EP Impurity A (C11H12O5) contains a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system. 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 | C11H12O5 |
| Molecular Weight | 224.21 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, ethanol, DMSO |
| 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 |
| CAS Registry Year (est.) | 2019 |
Related Repaglinide Standards
- Repaglinide Impurity 15 (CAS 88709-17-5)
- Repaglinide Impurity O (CAS 147770-03-4)
- Repaglinide Impurity 2 (CAS 219921-93-4)
- Repaglinide EP Impurity C (CAS 147769-93-5)
- Repaglinide Impurity 13 (CAS 332347-70-3)
- Repaglinide Impurity 10 (CAS CATO-C4X-118610)
- Repaglinide EP Impurity B (CAS 99469-99-5)
- Repaglinide Impurity 14 (CAS 72752-52-4)
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