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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. |
| Identification |
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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