Roxithromycin EP Impurity B CAS 214902-82-6
| CAS No. | 214902-82-6 |
| Molecular Formula | C33H62N2O12 |
| Molecular Weight | 678.85 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Structurally, Roxithromycin EP Impurity B (C33H62N2O12) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 4.0, corresponding to approximately 4 ring(s) or double-bond equivalent(s). With a molecular weight of 678.85 g/mol, it falls into the 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).
As a process- or degradation-related impurity, Roxithromycin EP Impurity B (CAS 214902-82-6, C33H62N2O12) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
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), Roxithromycin EP Impurity B 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 | C33H62N2O12 |
| Molecular Weight | 678.85 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.) | 2018 |
| Nitrogen Atoms | 2 |
Related Roxithromycin Standards
- Roxithromycin EP Impurity B Isomer (CAS CATO-C4X-130321)
- Roxithromycin Impurity 26 (CAS 134834-10-9)
- Roxithromycin EP Impurity H (CAS 425365-65-7)
- Roxithromycin EP Impurity E (CAS 1460313-66-9)
- Roxithromycin EP Impurity F (CAS 118267-18-8)
- Roxithromycin EP Impurity D (CAS 134931-00-3)
- Roxithromycin (CAS 80214-83-1)
- Roxithromycin EP Impurity J (CAS 134834-12-1)
Recommended Standards
- Cimiracemoside D (CAS 290821-39-5)
- Simvastatin, 1-Pyreneacetyl Ester (CAS 193682-18-7)
- N2,N7-Diphenyl-N2,N7-di-m-tolyl-9,9'-spirobi[fluorene]-2,7-diamine (CAS 1033035-83-4)
- Diketone-PEG4-Biotin (CAS 2353409-85-3)
- Moxifloxacin(R,R)-Nonane (CAS 151213-42-2)
- Neratinib Impurity 47 (CAS CATO-C4X-113447)
- Edaravone impurity 50 (CAS CATO-C4X-106250)
- 3-(difluoromethyl)cyclobutanecarboxylic acid (CAS 1613330-49-6)
- 1-(4-Fluoro-3-nitrophenyl)propan-1-one (CAS 777-48-0)
- (S)-N-((1R,2R)-2-(3-(3,5-Bis(trifluoromethyl)phenyl)ureido)cyclohexyl)-2-methylpropane-2-sulfinamide (CAS 934762-67-1)
- 7-methoxy-1,2-dihydronaphthalene (CAS 52178-91-3)
- 71022-43-0 AR-1H6620 adipic acid; 2,2-bis(hydroxymethyl)propane-1,3-diol; butyric acid; heptanoic acid (CAS 71022-43-0)
- 5-Bromo-4-fluoro-2-nitrophenol (CAS 944805-22-5)
- Semaglutide impurity 48 (CAS CATO-C4X-222648)
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