CAS: 2045402-27-3

Montelukast impurity I is an impurity found in the drug product, Montelukast. It is a natural substance and is produced as a result of metabolism studies. The chemical name for this impurity is 3-hydroxy-4-(2-methylpropyl)-5-(4-methoxyphenyl)pentanoic acid. This impurity can be used as an analytical standard and can be synthesized for use in pharmacopoeia. This compound has not been shown to have any therapeutic effects on humans or animals. This impurity has been shown to cause nausea, vomiting, and diarrhea in some patients.

Stability Hygroscopic Applications A hydroxylated impurity of the selective leukotriene D4-receptor antagonist, Montelukast (M568000).