PANTOPRAZOLE SODIUM

Product Overview

Description

PANTOPRAZOLE SODIUM

 

Specification :

 

TEST                               STANDARDS

Description                     White to off white crystalline.

Solubility                        Soluble in water and in methanol, practically insoluble in dichloromethane

PH                                   9.5-11.0

Identification
a) IR

b) UV

                                                    The infrared spectrum of a potassium bromide, dispersion of its concordant with that of reference spectrum off a Pantoprazole sodium sesquihydrate.

The U.V. absorption in the range 210nm to 360nm of 0.01% w/v sol. In Methanol exhibits about 289nm.

Colour and clarity          a) Solution should be clear
b) Absorbance at 420nm is not more than 0.125

Water Content
(By KFR)                         Not less than 4.0 % to Not more than 6.0 %

Heavy metal                  No more than 20PPM

Related substances by HPLC             Total Impurities: Not more than 0.8 %
Individual Impurity: Not more than 0.2%

Residual Solvents
Toluene
Acetone                        
No more than 0.005%
No more than 0.1%

Assay ( By HPLC )         Between 98 % to 101 %

Assay (By chemical)
(On anhydrous basis)    Between 99 % w/w to 101 % w/w