Azithromycin EP Impurity E CAS 612069-27-9
| CAS No. | 612069-27-9 |
| Molecular Formula | C36H68N2O12 |
| Molecular Weight | 720.93 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Azithromycin EP Impurity E is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
As a process- or degradation-related impurity, Azithromycin EP Impurity E (CAS 612069-27-9, C36H68N2O12) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, Azithromycin EP Impurity E is typically off-white to pale yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 720.93 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.
As a certified reference material (CRM), Azithromycin EP Impurity E 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.
Physical & Chemical Properties
| Molecular Formula | C36H68N2O12 |
| Molecular Weight | 720.93 g/mol |
| Purity | >90% |
| 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) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1985 |
| Nitrogen Atoms | 2 |
Related Azithromycin Standards
- Azithromycin Impurity 34 (CAS CATO-C4X-100334)
- Azithromycin EP Impurity N (CAS 612069-25-7)
- Azithromycin impurity 62 (CAS 857078-26-3)
- Azithromycin Impurity 38 (CAS CATO-C4X-100338)
- Azithromycin CP Impurity Q (CAS 99290-97-8)
- Azithromycin CP Impurity R (CAS 161193-44-8)
- Azithromycin Impurity 23 (CAS CATO-C4X-100323)
- Azithromycin Impurity 50 (CAS CATO-C4X-100350)
Recommended Standards
- N,N'-Bis(9,9-dimethyl-9H-fluoren-2-yl)-N,N'-diphenylbenzidine (CAS 361486-60-4)
- Erythromycin C reduced derivatives (CAS CATO-C4X-100169)
- N1-(1-Benzyl-3-hydroxy-5-phenyl-4-{[(1,3-thiazol-5-ylmethoxy)carbonyl]amino}pentyl)-N2-{[[(5-isopropyl-1,3-thiazol-2-yl)methyl](methyl)amino]carbonyl}valinamide (CAS 2096495-89-3)
- Erythromycin thiocyanate impurity B reduced derivative (CAS CATO-C4X-100166)
- Silodosin Impurity 30 (CAS 1639265-45-4)
- Upadacitinib Impurity 177 (CAS CATO-C4X-2405177)
- Fluocinolone Acetonide EP Impurity E (CAS 68352-03-4)
- Tert-butyl 5-fluoro-5-(hydroxymethyl)-2-azabicyclo[4.1.0]Heptane-2-carboxylate (CAS 2387601-41-2)
- 5-Amino-1-(4-fluorophenyl)-1H-pyrazole-4-carbonitrile (CAS 51516-70-2)
- Dioctadecylbis(3-phenylpropyl)silane (CAS 18822-34-9)
- U 62066 (CAS 87151-85-7)
- (5-(Methoxycarbonyl)-2-methylpyridin-3-yl)boronic acid (CAS 2225174-41-2)
- Benzo[b]thiophene-5-carboximidamide (CAS 71889-76-4)
- TRAF6 Control Peptide trifluoroacetate salt (CAS 852690-80-3)
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