Erlotinib Impurity 2 CAS 183321-85-9
| CAS No. | 183321-85-9 |
| Molecular Formula | C21H20ClN3O3 |
| Molecular Weight | 397.85 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Erlotinib Impurity 2 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
As a process- or degradation-related impurity, Erlotinib Impurity 2 (CAS 183321-85-9, C21H20ClN3O3) 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, chlorine substitution, Erlotinib Impurity 2 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 397.85 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), Erlotinib Impurity 2 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 | C21H20ClN3O3 |
| Molecular Weight | 397.85 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| 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 |
| CAS Registry Year (est.) | 2009 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 3 |
Related Erlotinib Standards
- Erlotinib Impurity 103 (CAS 299912-61-1)
- Erlotinib D4 (CAS 1130852-41-3)
- Erlotinib Impurity 93 (CAS 1058132-82-3)
- Erlotinib (CAS 183321-74-6)
- Erlotinib Impurity 39 (CAS CATO-C4X-106939)
- Erlotinib Impurity 55 (CAS 2410548-57-9)
- Erlotinib Impurity 96 (CAS CATO-C4X-106996)
- Erlotinib Impurity 3 (CAS 183321-82-6)
Recommended Standards
- Prucalopride Impurity 40（DP-3） (CAS 1900715-94-7)
- Rebamipide impurity 21 (CAS 452322-61-1)
- N-(3-chloro-4-fluorophenyl)-2-(2-(3,4-dimethoxyphenyl)acetyl)hydrazine-1-carbothioamide (CAS 882749-28-2)
- 1-(3-Chlorophenyl)-3-(1-(3-(pyridin-4-yl)-1,2,4-oxadiazol-5-yl)cyclohexyl)urea (CAS 1396856-26-0)
- Aripiprazole EP Impurity F (CAS 573691-09-5)
- Tafamidis Impurity 13 (CAS CATO-C4X-287713)
- Lysine Impurity 30 (CAS CATO-C4X-221130)
- Ethyl 2-cyclopropylthiazole-4-carboxylate (CAS 135207-08-8)
- 1-(3-Ethoxypropyl)-3-methylpiperidin-4-amine (CAS 1251328-62-7)
- 2-Amino-N-cyclohexylacetamide (CAS 16817-90-6)
- 3-Chloro-4-(4-fluoro-2-nitrophenoxy)benzoic acid (CAS 1306184-98-4)
- 3,4,5-Trimethylbenzoic Acid (CAS 1076-88-6)
- 1-(3-Methyl-4-nitrophenyl)-1h-imidazole (CAS 102791-92-4)
- Neuroendocrine Regulatory Peptide-4 (human, mouse, rat) (H-7266.1000) (CAS 922704-18-5)
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