Montelukast sodium
Montelukastum natricum
CAS151767-02-1FormulaC35H35ClNNaO3S
Montelukast sodium is a leukotriene receptor antagonist active substance. It is under evaluation with Indian manufacturers that hold EU documentation; enquiries help us prioritise.
Technical data
- CAS number
- 151767-02-1
- Molecular formula
- C35H35ClNNaO3S
- Molar mass
- 608.17 g/mol
- Pharmacopoeia / standards
- Ph. Eur. · USP
- Grade
- Ph. Eur. / USP, pharmaceutical grade
- Appearance
- Hygroscopic, white to off-white powder
- Typical packaging
- Sealed, light-protected containers (pack size per manufacturer)
Documents we provide
- CEP or ASMF (applicant’s part) with letter of access
- EU GMP certificate or inspection record (EudraGMDP)
- Written Confirmation (CDSCO)
- Specification and batch CoA
- Nitrosamine risk assessment
- Elemental impurities (ICH Q3D) and residual solvents (ICH Q3C) statements
- TSE/BSE statement
Typical package. The final list depends on the manufacturer and your specification.
Applications
Active substance for oral medicinal products made by authorised manufacturers.
Regulatory notes
Active substance under Directive 2001/83/EC. Imports from India require a Written Confirmation (Art. 46b). Supplied only to authorised manufacturers and wholesalers.
Quick answers
What is the CAS number of Montelukast sodium?
The CAS number of Montelukast sodium is 151767-02-1. Molecular formula: C35H35ClNNaO3S, molar mass 608.17 g/mol.
Which documents come with Montelukast sodium from Green Future Clinics?
The typical package includes: CEP or ASMF (applicant’s part) with letter of access; EU GMP certificate or inspection record (EudraGMDP); Written Confirmation (CDSCO); Specification and batch CoA. The final list depends on the manufacturer and on your specification.
Which grade of Montelukast sodium is available?
Ph. Eur. / USP, pharmaceutical grade. Reference standards: Ph. Eur., USP.
Verification
Identifiers checked against public databases on :