Afatinib impurity 42 CAS CATO-C4X-100642
| CAS No. | CATO-C4X-100642 |
| Molecular Formula | C14H6ClF2N5O4 |
| Molecular Weight | 381.68 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 Afatinib impurity 42.
CATO supplies Afatinib impurity 42 (CAS CATO-C4X-100642), a pharmacopoeial impurity reference standard (molecular formula C14H6ClF2N5O4, MW 381.68 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Afatinib impurity 42 (C14H6ClF2N5O4) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 13.0, corresponding to approximately 13 ring(s) or double-bond equivalent(s). With a molecular weight of 381.68 g/mol, it falls into the moderately-high-molecular-weight range. 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), Afatinib impurity 42 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 | C14H6ClF2N5O4 |
| Molecular Weight | 381.68 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at 2-8°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) | 13.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F/Cl-containing |
| Nitrogen Atoms | 5 |
Related Afatinib Standards
- Afatinib Impurity 73 (CAS CATO-C4X-100673)
- Afatinib Impurity 55 (CAS CATO-C4X-100655)
- Afatinib Impurity 62 (CAS CATO-C4X-100662)
- Afatinib Impurity 2 (CAS 314771-76-1)
- Afatinib Impurity 21 (CAS 402855-03-2)
- Afatinib Impurity 58 (CAS CATO-C4X-100658)
- Afatinib Impurity 90 (CAS CATO-C4X-100690)
- Afatinib Impurity 60 (CAS CATO-C4X-100660)
Recommended Standards
- Miconazole Impurity 15 (CAS 913837-72-6)
- Miconazole EP Impurity I (CAS 47363-37-1)
- 5-Chloro-4-(((2,6-dichlorobenzyl)oxy)methyl)-1-methyl-3-phenyl-1H-pyrazole (CAS 318248-47-4)
- Econazole (CAS 27220-47-9)
- Lubiprostone Impurity 40 (CAS CATO-C4X-113640)
- Pitavastatin Impurity 103 (CAS CATO-C4X-1037103)
- Dotinurad Impurity 61 (CAS 428458-98-4)
- 6-Hydroxy-2-methyl-5,7-dipropyl-1,3-diazaadamantane-2-carboxylic acid (CAS 1171935-08-2)
- 3-(Ethoxymethyl)-5-fluoropyridine (CAS 2364584-98-3)
- 4-Bromo-1-chloro-2-methanesulfonylbenzene (CAS 346729-65-5)
- Ethyl 4-aminobutanoate hydrochloride (CAS 6937-16-2)
- N1,N1-diethylcyclohexane-1,4-diamine dihydrochloride (CAS 1187927-93-0)
- Rubidium dihydrogen phosphate (CAS 13774-16-8)
- Semaglutide impurity 22(OtBu-Ste-γGlu(OtBu)-AEEA-AEEA-OH) (CAS 1118767-16-0)
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