Erlotinib Impurity 94 CAS 183320-19-6
| CAS No. | 183320-19-6 |
| Molecular Formula | C21H20ClN3O3 |
| Molecular Weight | N/A |
| 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 94.
As a process- or degradation-related impurity, Erlotinib Impurity 94 (CAS 183320-19-6, C21H20ClN3O3HCl) 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 94 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 434.32 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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).
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 94 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 HCl |
| Molecular Weight | 434.32 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 |
| 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
- Bromhexine EP Impurity E (CAS 1660957-93-6)
- Famotidine Impurity 84 (CAS CATO-C4X-139284)
- Atorvastatin Impurity 125 (CAS 1821498-27-4)
- (3R,4S)-4-isobutylpyrrolidine-3-carboxylic acid (CAS 261896-25-7)
- 3-(Difluoromethyl)-2-fluoro-5-formylisonicotinonitrile (CAS 1806844-83-6)
- 5-phenyl-1$l^{6},2-thiazolidine-1,1,3-trione (CAS 869467-25-4)
- 4-(4-(Benzyloxy)-2-methylbenzoyl)-5-(3-bromophenyl)-3-hydroxy-1-(3-methoxypropyl)-1H-pyrrol-2(5H)-one (CAS 500146-47-4)
- 2-(2H-1,2,3-triazol-4-yl)acetohydrazide (CAS 4332-47-2)
- 9-((4-(Dimethylamino)phenyl)amino)acridine-4-carboxylic acid (CAS 918889-42-6)
- Neuropeptide Y (18-36) (CAS 114495-97-5)
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