Cefuroxime Sodium EP Impurity I CAS 39684-61-2
| CAS No. | 39684-61-2 |
| Molecular Formula | C7H7NO4 |
| Molecular Weight | 169.13 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Compared with other compounds in its class, the molecular weight of 169.13 g/mol gives Cefuroxime Sodium EP Impurity I distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
As a process- or degradation-related impurity, Cefuroxime Sodium EP Impurity I (CAS 39684-61-2, C7H7NO4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Cefuroxime Sodium EP Impurity I (C7H7NO4) contains an amino-acid-derived structure, 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 | C7H7NO4 |
| Molecular Weight | 169.13 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (faint amine-like odor) |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO, water |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1968 |
| Nitrogen Atoms | 1 |
Related Cefuroxime Standards
- Cefuroxime Sodium Impurity 14 (CAS 69384-96-9)
- Cefuroxime Impurity 41 (CAS CATO-C4X-124541)
- Cefuroxime Axetil Impurity 7 (CAS 59176-08-8)
- Cefuroxime Impurity 58 (CAS 54434-94-5)
- Cefuroxime Impurity 35 (CAS 883-40-9)
- Cefuroxime Impurity 33 (CAS 1467-70-5)
- Cefuroxime Impurity 41 (CAS 75884-38-7)
- Cefuroxime Impurity 82 (CAS CATO-C4X-124582)
Recommended Standards
- Bumetanide Impurity 44 (CAS 84211-27-8)
- 5657-19-2 Furoylglycine Glycine, N-(2-furanylcarbonyl)- (9CI) Glycine, N-2-furoyl- 4-18-00-03955 (Beilstein Handbook Reference) BRN 0142378 N-(2-Furanylcarbonyl)glycine Furfuroylglycine Furoilglicina [Italian] N-(2-Furoyl)glycine 2-Furoylglycine Pyromucuric acid Furoilglicina (CAS 5657-19-2)
- Opicapone impurity 57 (CAS 3251-56-7)
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