Afatinib Impurity 30 CAS CATO-C4X-100630
| CAS No. | CATO-C4X-100630 |
| Molecular Formula | C20H21ClFN5O2 |
| Molecular Weight | 417.86 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Afatinib Impurity 30 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
As a process- or degradation-related impurity, Afatinib Impurity 30 (CAS CATO-C4X-100630, C20H21ClFN5O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution, Afatinib Impurity 30 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 417.86 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.
As a certified reference material (CRM), Afatinib Impurity 30 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 | C20H21ClFN5O2 |
| Molecular Weight | 417.86 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) | 12.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F/Cl-containing |
| Nitrogen Atoms | 5 |
Related Afatinib Standards
- Afatinib Impurity 32 (CAS 2170273-17-1)
- Afatinib Impurity 27 (CAS CATO-C4X-100627)
- Afatinib Impurity 66 (CAS CATO-C4X-100666)
- Afatinib Impurity 1 (CAS 314771-88-5)
- Afatinib Impurity 59 (CAS CATO-C4X-100659)
- Afatinib Impurity 17 (CAS CATO-C4X-100617)
- Afatinib Impurity 25 (CAS CATO-C4X-100625)
- Afatinib Impurity 34 (CAS CATO-C4X-100634)
Recommended Standards
- Tert-butyl (3-(4-chloro-2-(2-fluoro-6-methoxybenzoyl)phenyl)prop-2-yn-1-yl)carbamate (CAS 869366-70-1)
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- 6,8-Dibromo-7-iodoisochromane (CAS 2768875-76-7)
- (2S,4S)-1-(tert-Butoxycarbonyl)-4-[(3-chloro[1,1-biphenyl]-4-yl)oxy]-2-pyrrolidinecarboxylic acid (CAS 1354485-96-3)
- Apixaban Impurity 130 (CAS CATO-C4X-1088130)
- Cefalotin Impurity 6 (CAS 35565-06-1)
- Cefdinir Impurity 35 (CAS CATO-C4X-121035)
- 4-(3-Bromobenzoyl)-1-oxa-4-azaspiro[4.5]decane-3-carboxylic acid (CAS 1326810-46-1)
- 1,2,2,3-Tetrachloro-1,1-difluoropropane (CAS 1538604-30-6)
- 1-(3,4-Dimethylphenyl)-1H-pyrrole (CAS 383137-51-7)
- 7-Bromo-6-iodobenzo[d]thiazole (CAS 1326714-61-7)
- n-Cyclopentyl-5-nitropyrimidin-2-amine (CAS 1250185-89-7)
- 6-Bromo-1-(2-methoxyphenyl)-2-methyl-1H-indole-3-carbonitrile (CAS 922184-55-2)
- Prolactin-Releasing Peptide (12-31) (human) (CAS 235433-36-0)
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