Fentanyl EP Impurity H CAS CATO-C4X-134613
| CAS No. | CATO-C4X-134613 |
| Molecular Formula | C22H27ClN2O |
| Molecular Weight | 370.92 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, Fentanyl EP Impurity H (CAS CATO-C4X-134613, C22H27ClN2O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Fentanyl EP Impurity H (C22H27ClN2O) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
As a certified reference material (CRM), Fentanyl EP Impurity H 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 | C22H27ClN2O |
| Molecular Weight | 370.92 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| 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) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |
Related Fentanyl Standards
- Fentanyl isothiocyanate (CAS 85951-63-9)
- Fentanyl-D5 (CAS 118357-29-2)
- Fentanyl Impurity 1 (CAS 40871-01-0)
- Fentanyl Impurity 2 (CAS 173406-18-3)
- Fentanyl Related Compound B (10 mg) (4-Anilinopiperidine) (CAS 23056-29-3)
- Fentanyl Impurity 5 (CAS 51357-96-1)
- Fentanyl Related Compound B Hydrochloride salt (CAS 1193388-65-6)
- Fentanyl hydrochloride (CAS 1443-54-5)
Recommended Standards
- 3-Amino-4-((4-chlorophenyl)thio)-N,N-diethylbenzenesulfonamide (CAS 734546-72-6)
- 1-(3-Chlorophenyl)-N-((1-cyclopentylpiperidin-4-yl)methyl)methanesulfonamide (CAS 953260-30-5)
- 2-Chloro-N-(2-(pyrrolidin-1-yl)-2-(thiophen-3-yl)ethyl)benzenesulfonamide (CAS 954669-56-8)
- 1-(4-Chlorophenyl)-2-((5-(cyclopentylthio)-1,3,4-thiadiazol-2-yl)thio)ethan-1-one (CAS 477846-22-3)
- Lysine Impurity 13 trifluoroacetate salt (CAS CATO-C4X-221113)
- Ioversol impurity 28 (CAS CATO-C4X-209128)
- rac-Adrenaline EP Impurity D (CAS CATO-C4X-18494)
- (2,6-Difluorobenzyl)(3,5-difluorophenyl)sulfane (CAS 1443314-14-4)
- BOC-GLu(OBzl)-Gly-OH (CAS 51782-82-2)
- N4-(2-Chlorophenyl)-N2-(2-(2-hydroxyethoxy)ethyl)-L-asparagine (CAS 1048007-05-1)
- 1-Isopentyl-1H-pyrazole-4-carbonitrile (CAS 1708168-63-1)
- Temozolomide Impurity 22 (CAS 1114912-01-4)
- 2-Benzyl-3-hydroxy-2,3-dihydro-1H-isoindol-1-one (CAS 17448-14-5)
- Tirzepatide Impurity 48 (CAS CATO-C4X-324048)
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