Erlotinib Impurity 63 CAS CATO-C4X-106963
| CAS No. | CATO-C4X-106963 |
| Molecular Formula | C14H19ClO5 |
| Molecular Weight | 302.75 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 Erlotinib Impurity 63.
As a process- or degradation-related impurity, Erlotinib Impurity 63 (CAS CATO-C4X-106963, C14H19ClO5) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Erlotinib Impurity 63 (C14H19ClO5) contains a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, an aromatic ring system. The molecule exhibits a degree of unsaturation (DBE) of 5.0, corresponding to approximately 5 ring(s) or double-bond equivalent(s). With a molecular weight of 302.75 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), Erlotinib Impurity 63 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 | C14H19ClO5 |
| Molecular Weight | 302.75 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store in a cool place (≤25°C), keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
Related Erlotinib Standards
- Erlotinib Impurity 62 (CAS CATO-C4X-106962)
- Erlotinib Impurity 109 (CAS 476168-17-9)
- Erlotinib Impurity 30 (CAS CATO-C4X-106930)
- Erlotinib Impurity 31 (CAS CATO-C4X-106931)
- Erlotinib Impurity 58 (CAS CATO-C4X-106958)
- Erlotinib Impurity 59 (CAS CATO-C4X-106959)
- Erlotinib Impurity 81 (CAS CATO-C4X-106981)
- Erlotinib Impurity 82 (CAS CATO-C4X-106982)
Recommended Standards
- Azelastine Impurity 52 (CAS 1107016-94-3)
- Empagliflozin Impurity 154 (CAS 2452301-22-1)
- 4-Chloro-1-methyl-5-((2-methyl-1H-imidazol-1-yl)methyl)-2-phenyl-1,2-dihydro-3H-pyrazol-3-one (CAS 1023497-46-2)
- Fenofibrate EP Impurity C (CAS 217636-47-0)
- Daptomycin Impurity 34 (CAS CATO-C4X-137834)
- Atracurium EP Impurity S (CAS CATO-C4X-185019)
- Atogepant Impurity 71 (CAS CATO-C4X-328571)
- 2-(3-Bromophenyl)-2-fluoroacetic acid (CAS 1071455-00-9)
- 6-Fluoro-3-methyl-1H-indole (CAS 1011484-23-3)
- 3-(4-Phenyloxazol-5-yl)propanenitrile (CAS 89150-03-8)
- tert-Butyl ((1R,4R)-4-aminocyclopent-2-en-1-yl)carbamate (CAS 2455428-55-2)
- 2-(Benzo[d][1,3]dioxol-5-yloxy)acetohydrazide (CAS 588680-00-6)
- Ethyl 7-methyl-6-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)imidazo[1,2-a]pyridine-2-carboxylate (CAS 2377610-47-2)
- Tirzepatide Impurity 22 X TFA Salt (CAS CATO-C4X-324022)
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