Nintedanib Impurity 39 CAS 3395-81-1
| CAS No. | 3395-81-1 |
| Molecular Formula | C9H11ClO2 |
| Molecular Weight | 186.64 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 Nintedanib Impurity 39.
As a process- or degradation-related impurity, Nintedanib Impurity 39 (CAS 3395-81-1, C9H11ClO2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, an aromatic ring system, Nintedanib Impurity 39 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 186.64 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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), Nintedanib Impurity 39 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 | C9H11ClO2 |
| Molecular Weight | 186.64 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1957 |
| Halogen Content | Cl-containing |
Related Nintedanib Standards
- Nintedanib Impurity 44 (CAS 3395-80-0)
- Nintedanib Impurity 45 (CAS 70380-66-4)
- Nintedanib Impurity 67 (CAS 40872-87-5)
- Nintedanib Impurity 184 (CAS 873376-89-7)
- Nintedanib Impurity 38 (CAS 58378-33-9)
- Nintedanib Impurity 42 (CAS 2186-92-7)
- Nintedanib Impurity 43 (CAS 59276-28-7)
- Nintedanib Impurity 66 (CAS 707-07-3)
Recommended Standards
- Verapamil Impurity 27 (CAS 7306-46-9)
- Verapamil Impurity 25 (CAS 3893-01-4)
- Losartan EP Impurity D (CAS 83857-96-9)
- 1-(3-Chloro-2-methylpropyl)-2-fluoro-benzene (CAS 101975-64-8)
- Pranoprofen Impurity 50 ·xHCl (CAS CATO-C4X-181150)
- Baloxavir Marboxil Impurity 194 (CAS CATO-C4X-2108194)
- Abrocitinib Impurity 26 (CAS 2744171-53-5)
- N-(4-Chlorophenyl)-N-methyl-1-oxo-2-[(pyridin-2-yl)methyl]-1,2-dihydroisoquinoline-4-carboxamide (CAS 303995-37-1)
- 1-(2-((4-Bromopyridin-2-yl)oxy)ethyl)pyrrolidin-2-one (CAS 1610521-13-5)
- 11-(4-Fluorophenyl)-3-isobutyl-2,3,4,5,10,11-hexahydro-1H-dibenzo[b,e][1,4]diazepin-1-one (CAS 1022739-09-8)
- 4-n-Hexylbenzoic acid (CAS 21643-38-9)
- (5Z,9Z,13Z)-Teprenone (CAS 3796-67-6)
- 8-Bromo-1H-purine-2,6(3H,7H)-dione (CAS 10357-68-3)
- Peptide 433 (CAS CATO-CPTD788433)
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