Azithromycin EP Impurity F CAS 612069-28-0
| CAS No. | 612069-28-0 |
| Molecular Formula | C38H70N2O13 |
| Molecular Weight | 762.97 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Azithromycin EP Impurity F.
As a process- or degradation-related impurity, Azithromycin EP Impurity F (CAS 612069-28-0, C38H70N2O13) 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 F is typically off-white to pale yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 762.97 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 F 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 | C38H70N2O13 |
| Molecular Weight | 762.97 g/mol |
| Purity | >95% |
| 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) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1985 |
| Nitrogen Atoms | 2 |
Related Azithromycin Standards
- Azithromycin EP Impurity K (CAS 612534-95-9)
- Azithromycin EP Impurity O (CAS 763924-54-5)
- Azithromycin N-Ethyl (CAS 92594-45-1)
- Azithromycin impurity 57 (CAS CATO-C4X-100357)
- Azithromycin EP Impurity L (CAS 90503-06-3)
- Azithromycin EP Impurity D (CAS 612069-26-8)
- Azithromycin impurity 58 (CAS CATO-C4X-100358)
- Azithromycin Impurity 28 (CAS CATO-C4X-100328)
Recommended Standards
- Erythromycin A 9-Methoxime (CAS 53066-26-5)
- Clarithromycin EP Impurity L (CAS 127253-05-8)
- 4,4'-(Ethane-1,2-diylbis((2-((4-sulfophenyl)amino)ethyl)azanediyl))dibenzenesulfonic acid (CAS 2410-53-9)
- Clarithromycin EP Impurity C (CAS 127253-06-9)
- Clopidogrel Impurity 105 (CAS CATO-C4X-1029105)
- Tramadol Impurity 20 (CAS CATO-C4X-149820)
- Nilotinib EP Impurity B (CAS 18595-18-1)
- tert-Butyl (4-((4-chloropyrimidin-2-yl)amino)cyclohexyl)carbamate (CAS 1289385-84-7)
- 4-Hydrazinylpyridine hydrobromide (CAS 1351610-78-0)
- Anthraquinone-2-carboxylic Acid (CAS 117-78-2)
- 97-35-8 3-Amino-N,N-diethyl-4-methoxybenzenesulphonamide Benzenesulfonamide, 3-amino-N,N-diethyl-4-methoxy- Metanilamide, N1,N1-diethyl-4-methoxy- (8CI) C.I. 37150 Brentamine Fast Red ITR Base N1,N1-Diethyl-4-methoxymetanilamide EINECS 202-575-5 Fast Red ITR Base 2-Methoxy-5-(diethylaminosulfonyl)aniline 2-Methoxy-5-(diethylsulfamoyl)aniline NSC 50670 Orle Base Fast Red ITR Red ITR base (CAS 97-35-8)
- H-Glu-Glu-Asp-OH (CAS 130778-96-0)
- 2',3'-Di-O-acetyl-D-uridine (CAS 29108-90-5)
- Semaglutide Impurity 150 xTFA (CAS CATO-C4X-2226150)
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