Pantoprazole Sodium Sesquihydrate

SL.

NO.

                                                        TESTS

                          RESULTS

                            SPECIFICATIONS

01

02

03

04

05

06

07

Description

Solubility

Identification

a)      By IR

b)      By HPLC

Water by K.F

Heavy metals

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)

Complies

Complies

Complies

5.21% w/w

Less than 20 p pm

0.16%

0.57%

98.43%w/w

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