Pantoprazole Sodium Sesquihydrate
a) By IR
b) By HPLC
Water by K.F
Related Substances (by HPLC% area normalization)
a) Single Impurity
b) Total Impurity
Assay (% w/w by HPLC, as C16 F2H14 N3 NaO4S on Anhydrous basis)
Less than 20 p pm
White to almost white colored crystalline powder.
Soluble in Water and practically insoluble in Dichloride methane.
Should match with that of standard.
The sample RT should correspond with that if standard
Between 4.5% and 8.0% w/w
Not more than 20 p pm
Not more than 0.5%
Not more than 1.0%
Between 98.0% to 102.0% w/w