Crizotinib impurity 13 CAS CATO-C4X-102513
| CAS No. | CATO-C4X-102513 |
| Molecular Formula | C21H22Cl2FN5O2 |
| Molecular Weight | 466.34 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Crizotinib impurity 13 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.
Crizotinib impurity 13 (CAS CATO-C4X-102513) is a certified pharmaceutical impurity reference standard with the molecular formula C21H22Cl2FN5O2 and a molecular weight of 466.34 g/mol.
Structurally, Crizotinib impurity 13 (C21H22Cl2FN5O2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine/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 466.34 g/mol, it falls into the moderately-high-molecular-weight range. 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), Crizotinib impurity 13 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 | C21H22Cl2FN5O2 |
| Molecular Weight | 466.34 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 Crizotinib Standards
- Crizotinib impurity 12 (CAS CATO-C4X-102512)
- Crizotinib impurity 21 (CAS CATO-C4X-102521)
- Crizotinib impurity 25 (CAS CATO-C4X-102525)
- Crizotinib 2-Keto Impurity (CAS 1415558-82-5)
- Crizotinib-d5 (CAS 1395950-48-7)
- Crizotinib impurity 34 (CAS CATO-C4X-102534)
- Crizotinib impurity 35 (CAS CATO-C4X-102535)
- Crizotinib impurity 40 (CAS CATO-C4X-102540)
Recommended Standards
- N-[4-({1-[(3,4-dichlorophenyl)methyl]-6-oxo-1,6-dihydropyridin-3-yl}sulfamoyl)phenyl]acetamide (CAS 339009-16-4)
- JI-101 (CAS 900573-88-8)
- Mosapride Impurity 22 (CAS CATO-C4X-104422)
- Ethacrynic Acid Mercapturate (Mixture of diastereomers (CAS 54546-23-5)
- Axitinib Impurity N24 (CAS 119-80-2)
- Prasugrel Impurity 13 (CAS 2091625-61-3)
- Dyclonine Impurity 38 (CAS CATO-C4X-188138)
- 2-Bromo-5,6,7,8-tetrahydro-4H-pyrazolo[1,5-a]azepin-4-one (CAS 2750605-58-2)
- 1-(3,4-Dimethylphenyl)pyrrolidin-2-one (CAS 343375-66-6)
- 2-[(3,4-Dimethylphenyl)amino]benzoic Acid (CAS 39492-53-0)
- (4-(Aminomethyl)phenyl)(2,6-dimethylmorpholino)methanone (CAS 923170-88-1)
- N-(4-Methoxybenzyl)-4-(trifluoromethyl)benzamide (CAS 554408-00-3)
- Ethyl 4-fluoro-1,2-dihydro-2-oxo-3-pyridinecarboxylate (CAS 1803770-29-7)
- Liraglutide(3-31)TFA Salt (CAS CATO-C4X-19921)
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