Dotinurad Impurity 116 CAS CATO-C4X-2494116
| CAS No. | CATO-C4X-2494116 |
| Molecular Formula | C8H5Cl3O3 |
| Molecular Weight | 255.48 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 Dotinurad Impurity 116.
CATO supplies Dotinurad Impurity 116 (CAS CATO-C4X-2494116), a pharmacopoeial impurity reference standard (molecular formula C8H5Cl3O3, MW 255.48 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Dotinurad Impurity 116 (C8H5Cl3O3) 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 255.48 g/mol, it falls into the medium-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.
The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.
Physical & Chemical Properties
| Molecular Formula | C8H5Cl3O3 |
| Molecular Weight | 255.48 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | ≥95% |
| Storage | Store in a cool place (≤25°C), keep sealed and dry, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO |
| 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 Dotinurad Standards
- Dotinurad Impurity 100 (CAS 723287-01-2)
- Dotinurad Impurity 94 (CAS CATO-C4X-249494)
- Dotinurad Impurity 164 (CAS CATO-C4X-2494164)
- Dotinurad Impurity 182 (CAS CATO-C4X-2494182)
- Dotinurad Impurity 139 (CAS CATO-C4X-2494139)
- Dotinurad Impurity 213 (CAS CATO-C4X-2494213)
- Dotinurad Impurity 142 (CAS CATO-C4X-2494142)
- Dotinurad Impurity 40 (CAS CATO-C4X-249440)
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