Montelukast EP Impurity H CAS 906107-37-7
| CAS No. | 906107-37-7 |
| Molecular Formula | C34H32ClNO4S |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage, chlorine substitution, Montelukast EP Impurity H is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 622.60 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
Montelukast EP Impurity H (CAS 906107-37-7) is a certified pharmaceutical impurity reference standard with the molecular formula C34H32ClNO4SHCl and a molecular weight of 622.60 g/mol.
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), 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 HCl |
| Molecular Weight | 622.60 g/mol |
| Purity | 97%+ |
| 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.) | 1987 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
| Sulfur Atoms | 1 |
Related Montelukast Standards
- Montelukast Impurity 50 (CAS 1044705-96-5)
- Montelukast Impurity 47 (CAS 1079753-36-8)
- Montelukast-d6 (CAS 1093746-29-2)
- Montelukast Impurity 56 (CAS 1100617-38-6)
- Montelukast Impurity 44 (CAS 115104-40-0)
- Montelukast R-Sulfoxide (CAS 1152185-58-4)
- Montelukast EP Impurity E (CAS 1187586-58-8)
- Montelukast EP Impurity D (CAS 1187586-61-3)
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