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Home » Products » Active Pharma Ingredients » Pantoprazole Sodium Sesquihydrate

Pantoprazole Sodium Sesquihydrate



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Product Description

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

 

Product Code : 19


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