Mizolastine Impurity 1 CAS 108635-83-2
| CAS No. | 108635-83-2 |
| Molecular Formula | C20H23FN4 |
| Molecular Weight | 338.42 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Mizolastine Impurity 1 is closely related to a nitrogen-containing heterocyclic scaffold, a nitrile group, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
Mizolastine Impurity 1 (CAS 108635-83-2) is a certified pharmaceutical impurity reference standard with the molecular formula C20H23FN4 and a molecular weight of 338.42 g/mol.
Structurally, Mizolastine Impurity 1 (C20H23FN4) contains a nitrogen-containing heterocyclic scaffold, a nitrile group, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 11.0, corresponding to approximately 11 ring(s) or double-bond equivalent(s). With a molecular weight of 338.42 g/mol, it falls into the moderately-high-molecular-weight range. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
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), Mizolastine Impurity 1 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 | C20H23FN4 |
| Molecular Weight | 338.42 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 11.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1988 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 4 |
Related Mizolastine Standards
- Mizolastine impurity 12 (CAS CATO-C4X-200612)
- Mizolastine impurity 16 (CAS CATO-C4X-200616)
- Mizolastine Impurity 8 (CAS CATO-C4X-20068)
- Mizolastine Impurity 10 (CAS CATO-C4X-200610)
- Mizolastine Impurity 7 (CAS CATO-C4X-20067)
- Mizolastine impurity 11 (CAS CATO-C4X-200611)
- Mizolastine Impurity 3 (CAS CATO-C4X-20063)
- Mizolastine Impurity 4 (CAS 935860-15-4)
Recommended Standards
- Brinzolamide Impurity 16 (CAS 171273-35-1)
- Firocoxib Impurity 2 (CAS CATO-C4X-32112)
- Biotin impurity 23 (CAS 33607-57-7)
- Firocoxib Impurity 3 (CAS CATO-C4X-32113)
- Dronedarone Impurity 42 (CAS 113385-32-3)
- Thymalfasin Impurity 9 (CAS CATO-C4X-18989)
- Baricitinib Impurity 36 (CAS 1919837-50-5)
- 3-Isopropyl-N5,1-dimethyl-1H-pyrazole-4,5-diamine (CAS 169261-04-5)
- 4-Hydroxy-1-methyl-N-phenyl-1H-thieno[3,2-c][1,2]thiazine-3-carbothioamide 2,2-dioxide (CAS 303987-83-9)
- 2,6-Bis(4-phenyl-4,5-dihydrooxazol-2-yl)pyridine (CAS 342043-03-2)
- 4-(2-Morpholinoethyl)thiazol-2-amine (CAS 376636-15-6)
- 8-Benzyl-4-(4-chloro-2-fluorobenzoyl)-1-oxa-4,8-diazaspiro[4.5]decane-3-carboxylic acid (CAS 1326813-69-7)
- 2-Methyl-3-(4-methylthiazole-5-carboxamido)propanoic acid (CAS 1248143-44-3)
- Peptide Impurity (CAS CATO-CPTD788810)
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