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Home Active Pharmaceutical Ingredients pantoprazole sodium
Product Name : Pantoprazole Sodium BP/EP/USP
Chemical Name : 5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole
CAS Number : 164579-32-2
Chemical Formula : C16H14F2N3NaO4S
Molecular Mass : 405.46 g/mol
Therapeutic Category : Proton-pump Inhibitors

Test Specification
Description A White to off white powder.

The retention time of sample should concordant with the retention time of the standard.

Exhibits maximum at about 289nm

Solubility Freely soluble in methanol and water, soluble in ethanol
Heavy Metals NMT 10
Ph (1% Solution) Between 10 and 11
Assay on dried basis by HPLC

NLT 98.0 and NMT 101.0

NLT 98.0 and NMT 101.0

Water Content by KF Not less than 4.0 and NMT 8.0
Related Substances by HPLC

Individual Impurity : Not more than 0.5

Unidentified impurity: Not more than 0.3

Total Impurities : Not more than 1.0

Additional Tests

the IR absorption spectrum of the preparation of the test specimen, exhibits maxima only at the same wavelength as that of similar preparation of the corresponding Pantoprazole sodium sesquihydrate working standard.

Comply with the test for

Clarity & Colour Solution

a) Absorbance at 420nm is not more than 0.125

b) Solution should be clear

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