Category:
Active Pharmaceutical Ingredients
CAS NO:
158966-92-8
Standard:
EP,
Montelukast Impurity 5 is a critical synthetic byproduct defined as (R)-2-[1-[(4-chlorophenyl)amino]-1-oxopropyl]-N-(4-hydroxyphenyl)acetamide. Its molecular formula is C19H18ClNO3 and CAS number is 206570-75-8. This impurity arises during the condensation steps of montelukast sodium manufacturing.
Store at -20°C in a desiccated environment away from light. Personnel must wear appropriate PPE including gloves and goggles to prevent skin contact. Do not use in clinical trials; strictly limited to analytical laboratory applications.