Erlotinib Impurity 53 CAS 183365-34-6
| CAS No. | 183365-34-6 |
| Molecular Formula | C21H21N3O4 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.
As a process- or degradation-related impurity, Erlotinib Impurity 53 (CAS 183365-34-6, C21H21N3O4HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Erlotinib Impurity 53 (C21H21N3O4HCl) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 12.0, corresponding to approximately 12 ring(s) or double-bond equivalent(s). With a molecular weight of 415.87 g/mol, it falls into the moderately-high-molecular-weight range. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
As a certified reference material (CRM), Erlotinib Impurity 53 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 | C21H21N3O4 HCl |
| Molecular Weight | 415.87 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| 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 |
| CAS Registry Year (est.) | 2009 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 3 |
Related Erlotinib Standards
- Erlotinib Impurity 97 (CAS 1012057-39-4)
- Erlotinib Impurity 93 (CAS 1058132-82-3)
- Erlotinib impurity 136 (CAS 1058651-74-3)
- Erlotinib D4 (CAS 1130852-41-3)
- Erlotinib Impurity 123 (CAS 1145671-36-8)
- Erlotinib Hydrochloride Impurity 3 (CAS 1145671-52-8)
- Erlotinib Impurity 51 (CAS 115665-66-2)
- Erlotinib-d6 HCl (CAS 1189953-78-3)
Recommended Standards
- Cefmetazole Impurity 3 (CAS 70993-70-3)
- Methotrexate Impurity 64 (CAS 52980-66-2)
- Dabigatran Impurity 136 (CAS 1015167-27-7)
- (4-Aminophenyl)(4-(2-methoxyphenyl)piperazin-1-yl)methanone (CAS 302333-22-8)
- 2-Bromo-3-(difluoromethyl)-5-(hydroxymethyl)pyridin-4-ol (CAS 1806866-24-9)
- Isoquinolin-3-yl(phenyl)methanone (CAS 83629-95-2)
- 3-(1-Ethyl-1H-indol-3-yl)propanoic acid (CAS 91957-27-6)
- 4-(3-Oxo-1,3,4,5,6,7-hexahydro-2H-indazol-2-yl)benzoic acid (CAS 866018-45-3)
- 9-Methyl-6-(pyrrolidin-1-yl)-9H-purin-2-amine (CAS 920317-06-2)
- Acetyl-(Leu28·31)-Neuropeptide Y (24-36) (CAS 155709-24-3)
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