Afatinib Impurity 11 CAS CATO-C4X-100611
| CAS No. | CATO-C4X-100611 |
| Molecular Formula | C24H25ClFN5O4 |
| Molecular Weight | 501.94 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.
CATO supplies Afatinib Impurity 11 (CAS CATO-C4X-100611), a pharmacopoeial impurity reference standard (molecular formula C24H25ClFN5O4, MW 501.94 g/mol) used for the identification and quantification of trace impurities in APIs.
Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution, Afatinib Impurity 11 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 501.94 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.
Physical & Chemical Properties
| Molecular Formula | C24H25ClFN5O4 |
| Molecular Weight | 501.94 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| 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; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 14.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F/Cl-containing |
| Nitrogen Atoms | 5 |
Related Afatinib Standards
- Afatinib dichloro impurity (CAS 2223677-63-0)
- Afatinib Impurity 4 (CAS CATO-C4X-10064)
- Afatinib Impurity 57 (CAS CATO-C4X-100657)
- Afatinib Impurity 87 (CAS CATO-C4X-100687)
- Afatinib-d6 (CAS 1313874-96-2)
- Afatinib Impurity 47 (CAS CATO-C4X-100647)
- Afatinib Impurity 36 (CAS CATO-C4X-100636)
- Afatinib Impurity 63 (CAS CATO-C4X-100663)
Recommended Standards
- 2-(4-Fluorophenyl)benzo[d]imidazo[2,1-b]thiazole (CAS 7067-87-0)
- Pitolisant impurity 24 (CAS CATO-C4X-252024)
- Baloxavir Marboxil Impurity 179 (CAS CATO-C4X-2108179)
- 4-(((7-Chloro-2-(hydroxymethyl)-3-methyl-4-oxo-3,4-dihydroquinazolin-6-yl)methyl)(prop-2-ynyl)amino)-N-(pyridin-3-ylmethyl)benzamide (CAS 1258400-25-7)
- Nicorandil impurity 58 (CAS CATO-C4X-190758)
- Vonoprazan Impurity 115 (CAS CATO-C4X-1020115)
- Loxoprofen Impurity 165 (CAS 63178-03-0)
- 1,3-Benzenedicarboxylic acid, polymer with N1-(2-aminoethyl)-1,2-ethanediamine and 2-(chloromethyl)oxirane (CAS 61981-24-6)
- Ethyl 3-amino-3-(4-ethoxy-3-methoxyphenyl)propanoate (CAS 613656-39-6)
- 3-Amino-1-Boc-5,5-difluoropiperidine (CAS 1258638-82-2)
- 1,2-Ethanediamine, polymer with 2-methyloxirane (CAS 25214-63-5)
- 7-ethyl-6,7-dihydro-5H-pyrazolo[1,5-a]pyridin-4-one (CAS 2489783-91-5)
- 4-(trans-4-Propylcyclohexyl)-[1,1-biphenyl]-4-carbonitrile (CAS 94412-40-5)
- Bonemarrow-Derived Mesenchymal Stem Cells Affinity Peptide trifluoroacetate salt (CAS 683750-83-6)
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