Montelukast EP Impurity I CAS 2045402-27-3
| CAS No. | 2045402-27-3 |
| Molecular Formula | C35H36ClNO4S |
| Molecular Weight | 602.18 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Montelukast EP Impurity I (CAS 2045402-27-3, C35H36ClNO4S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Montelukast EP Impurity I (C35H36ClNO4S) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.
As a certified reference material (CRM), Montelukast EP Impurity I 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 | C35H36ClNO4S |
| Molecular Weight | 602.18 g/mol |
| Purity | >95% |
| Storage | Store at room temperature, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| 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.) | 1997 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
| Sulfur Atoms | 1 |
Related Montelukast Standards
- 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 Impurity 23 (CAS CATO-C4X-103123)
- Montelukast EP Impurity C(Mixture of Diastereomers) (CAS 909849-96-3)
- Montelukast Impurity 46 (CAS CATO-C4X-103146)
Recommended Standards
- 21(S)-Hydroxy Montelukast (CAS 184763-29-9)
- Montelukast Impurity 59 (CAS CATO-C4X-103159)
- cis-Montelukast Sulfoxide (CAS 1428511-42-5)
- 2,6,10-Tribromo-4,4,8,8,12,12-hexamethyl-4H,8H,12H-benzo[1,9]quinolizino[3,4,5,6,7-defg]acridine (CAS 928642-02-8)
- Lenvatinib Impurity 16 (CAS 69332-65-6)
- Paliperidone USP Related Compound C (CAS 130049-82-0)
- Ziprasidone Impurity 19 (CAS 147124-37-6)
- N-(4-(2-(allylamino)thiazol-4-yl)phenyl)acetamide hydrobromide (CAS 1274903-95-5)
- 2-Methyl-7-(2-morpholinoethoxy)-3-phenyl-4H-chromen-4-one (CAS 32131-81-0)
- 3-Indolebutyric Acid (CAS 133-32-4)
- Sulfadimethoxine Impurity (CAS 98627-35-1)
- 1-(2-Bromo-3-(difluoromethoxy)phenyl)propan-1-one (CAS 1261511-09-4)
- Imidazo[1,5-α]pyridine-5-carbaldehyde (CAS 85691-71-0)
- Semaglutide impurity 274 (CAS CATO-C4X-2226274)
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