Fluconazole EP Impurity I (R-Isomer) CAS CATO-C4X-101967
| CAS No. | CATO-C4X-101967 |
| Molecular Formula | C13H14F2N7O |
| Molecular Weight | 322.29 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a certified reference material (CRM), Fluconazole EP Impurity I (R-Isomer) 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.
Fluconazole EP Impurity I (R-Isomer) (CAS CATO-C4X-101967) is a certified pharmaceutical impurity reference standard with the molecular formula C13H14F2N7O and a molecular weight of 322.29 g/mol.
The molecular framework of Fluconazole EP Impurity I (R-Isomer) (C13H14F2N7O) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
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.
Physical & Chemical Properties
| Molecular Formula | C13H14F2N7O |
| Molecular Weight | 322.29 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | ≥95% |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 9.5 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F-containing |
| Nitrogen Atoms | 7 |
Related Fluconazole Standards
- Fluconazole EP Impurity I (CAS 749821-19-0)
- Fluconazole N-Oxide (CAS 1997296-62-4)
- Fluconazole Impurity 52 (CAS CATO-C4X-101952)
- Fluconazole Impurity 48 (CAS 1222655-38-0)
- Fluconazole Impurity 61 (CAS CATO-C4X-101961)
- Fluconazole Impurity 72 (CAS CATO-C4X-101972)
- Fluconazole Impurity 73 (CAS CATO-C4X-101973)
- Fluconazole EP Impurity H (CAS 150194-52-8)
Recommended Standards
- Sulfasalazine EP Impurity I (CAS 21542-82-5)
- Sulfasalazine EP Impurity I (CAS 1310803-27-0)
- Norfloxacin Impurity 47 (CAS CATO-C4X-146847)
- benzo[d][1,3]dioxol-5-yldiphenylphosphine oxide (CAS 209981-66-8)
- Indometacin Impurity 55 (CAS CATO-C4X-147055)
- Ramipril Impurity 4 (CAS 122076-80-6)
- Bifonazole impurity 23 (CAS CATO-C4X-156023)
- 3-(1-Aminopropan-2-yl)azetidin-3-ol (CAS 1526480-37-4)
- N-Cyclopropyl-5-(1-isopropylpiperidin-2-yl)pyridin-2-amine (CAS 1352515-99-1)
- 2-Chloro-1-phenylethanol (CAS 1674-30-2)
- 2-(1-Ethyl-1h-1,2,4-triazol-5-yl)-2-phenylethan-1-amine (CAS 1310125-40-6)
- 1-(Furan-2-yl)-2-(piperidin-2-yl)ethan-1-one (CAS 1515421-30-3)
- 2-Bromo-4-formyl-6-methoxyphenyl acetate (CAS 308088-29-1)
- Tirzepatide Impurity 47 (CAS CATO-C4X-324047)
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