Montelukast Impurity 35 CAS 1351973-25-5
| CAS No. | 1351973-25-5 |
| Molecular Formula | C36H38ClNO3S |
| Molecular Weight | 600.21 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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 process- or degradation-related impurity, Montelukast Impurity 35 (CAS 1351973-25-5, C36H38ClNO3S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Montelukast Impurity 35 (C36H38ClNO3S) contains a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage, chlorine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
As a certified reference material (CRM), Montelukast Impurity 35 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 | C36H38ClNO3S |
| Molecular Weight | 600.21 g/mol |
| Purity | >95% |
| Storage | Store at room temperature, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 18.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1991 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
| Sulfur Atoms | 1 |
Related Montelukast Standards
- Montelukast Impurity 30 (CAS 855473-51-7)
- Montelukast R-Sulfoxide (CAS 1152185-58-4)
- Montelukast EP Impurity I (CAS 184763-26-6)
- Montelukast 1,2-Diol (Mixture of Diastereomers) (CAS 186352-97-6)
- Montelukast - Impurity C (sodium Salt) (CAS 909796-71-0)
- Montelukast Hydroxy (CAS 679838-32-5)
- Montelukast EP Impurity I (CAS 2045402-27-3)
- Montelukast Impurity 23 (CAS CATO-C4X-103123)
Recommended Standards
- Copper, [2,7,12,17-tetrakis(1,1-dimethylethyl)-21H,23H-porphyrazinato(2-)-κN21,κN22,κN23,κN24]-, (SP-4-1)- (CAS 65124-35-8)
- 2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11-Icosafluoroundecyl methacrylate (CAS 41123-44-8)
- Crizotinib impurity 26 (CAS CATO-C4X-102526)
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- Dobutamine Impurity 60 (CAS 63434-00-4)
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- 5-Bromo-2-hydrazinyl-4-methylpyridine (CAS 913839-67-5)
- N-((5-ethylthiophen-2-yl)methyl)thietan-3-amine (CAS 1865219-63-1)
- 1-Propylcyclobutan-1-amine hydrochloride (CAS 1713160-67-8)
- Sucrose palmitate (CAS 26446-38-8)
- [pGlu] Semaglutide (CAS CATO-C4X-2226288)
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