孟鲁司特钠 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