孟魯司特鈉 Montelukast Sodium
151767-02-1
White or off-white crystalline powder
Identification
A. IR: positive
B. HPLC: positive
C. Reaction of sodium: positive
Enantiomeric purity: positive
Solubility
Freely soluble in water,ethanol,methanol and methylene chloride, Practically insoluble in acetonitrile
Specific optical rotation +100° ~ ＋110°
Alkalinity 8.7~10.2
Water NMT 4.0 %
Related substances
Methylstyrene impurity (impurityB ) : NMT 0.3%
Sulfoxide impurity ( impurityC ) : NMT 0.2%
Michael Adducts 1 and 2 ( impurityD/E ) : NMT 0.15%
Methylketone impurity ( impurityF ) : NMT 0.15%
Cis-isomer ( impurityG ) : NMT 0.15%
Any other individual impurity: NMT 0.1%
Total impurities: NMT 0.6%
Impurity J(MT-B3) NMT 0.1%
Enantiomeric Purity NMT 0.2%
Residual solvents Methanol: NMT 0.3%
Assay 98.0%～102.0%(C35H35CINaNO3S, on anhydrous basis)
Conclusion Conforms to USP42
