Azithromycin Impurity 4 CAS CATO-C4X-10034
| CAS No. | CATO-C4X-10034 |
| Molecular Formula | C30H58N2O9 |
| Molecular Weight | 590.79 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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 process- or degradation-related impurity, Azithromycin Impurity 4 (CAS CATO-C4X-10034, C30H58N2O9) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Azithromycin Impurity 4 (C30H58N2O9) contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 3.0, corresponding to approximately 3 ring(s) or double-bond equivalent(s). With a molecular weight of 590.79 g/mol, it falls into the moderately-high-molecular-weight range. 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).
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 | C30H58N2O9 |
| Molecular Weight | 590.79 g/mol |
| Appearance | White to pale yellow crystalline powder |
| Purity | 97%+ |
| 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) | 3.0 |
| UV Absorption | UV-absorbing |
| Nitrogen Atoms | 2 |
Related Azithromycin Standards
- Azithromycin EP Impurity J (CAS 117693-41-1)
- Azithromycin Impurity 44 (CAS 2365312-76-9)
- Azithromycin impurity 22 (CAS CATO-C4X-100322)
- Azithromycin Impurity 33 (CAS CATO-C4X-100333)
- Azithromycin Impurity 38 (CAS CATO-C4X-100338)
- Azithromycin impurity 62 (CAS 857078-26-3)
- Azithromycin EP Impurity N (CAS 612069-25-7)
- Azithromycin Impurity 34 (CAS CATO-C4X-100334)
Recommended Standards
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- Glucagon-like peptide 2 (CAS 89750-15-2)
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