Usage | Commercial |
DOCUSATE SODIUM USP |
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Sr. No |
Tests |
Limits |
|
1 |
Description |
White, wax - like plastic solid, having a characteristic odor suggestive of octyl alcohol, but no odor of other solvents. |
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2 |
Solubility |
Very soluble in solvent hexane; freely soluble in alcohol and in glycerin; sparingly soluble in water |
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3 |
Identification By IR |
The IR absorption spectrum of the film exhibits maxima only at the same wavelengths as that of a similar preparation of USP Docusate Sodium Reference Standard. |
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4 |
Assay |
Not less than 99.0% and Not more than 100.5 % (anhydrous basis) as per USP Standard. |
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5 | Impurities | ||
5.1 Inorganic Impurities | |||
Residue on ignition | Between 15.5% and 16.5%, Calculated on the anhydrous basis. | ||
Heavy metals | Not more than 10 ppm | ||
5.2 Organic Impurities | |||
Limit Of Bis (2-ethylhexyl) MALEATE | Not more than 0.4% | ||
6 | Specific Tests | ||
Water Determination | Not more than 2.0% | ||
Clarity Of Solution | The Sample solution does not develop a haze within 24 hours. |
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