Montelukast EP Impurity H CAS 851755-56-1
| CAS No. | 851755-56-1 |
| Molecular Formula | C34H32ClNO4S |
| Molecular Weight | 586.14 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.
Montelukast EP Impurity H (CAS 851755-56-1) is a certified pharmaceutical impurity reference standard with the molecular formula C34H32ClNO4S and a molecular weight of 586.14 g/mol.
Structurally, Montelukast EP Impurity H (C34H32ClNO4S) contains a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 19.0, corresponding to approximately 19 ring(s) or double-bond equivalent(s). With a molecular weight of 586.14 g/mol, it falls into the moderately-high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
As a certified reference material (CRM), Montelukast EP Impurity H 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 | C34H32ClNO4S |
| Molecular Weight | 586.14 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) | 19.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1987 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
| Sulfur Atoms | 1 |
Related Montelukast Standards
- Montelukast Impurity 24 (CAS CATO-C4X-103124)
- Montelukast (CAS 158966-92-8)
- Montelukast EP Impurity A (CAS 220927-27-5)
- Montelukast EP Impurity G (CAS 774538-96-4)
- Montelukast Amide (CAS 866923-63-9)
- Montelukast Impurity 2 (CAS CATO-C4X-10312)
- Montelukast Impurity N1 (CAS 162489-70-5)
- Montelukast Impurity 21 (CAS 142147-67-9)
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