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DOCUSATE SODIUM
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| MOLECULAR WEIGHT: C20H37NaO7S |
MOLECULAR FORMULA: : 444.6
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TEST |
USP |
EP / BP |
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CHARACTERS |
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White or almost white, waxy masses or flakes,. |
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CLARITY OF SOLUTION
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Dissolve 25 g in 100 mL of alcohol: the solution does not develop a haze within 24 hours
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hygroscopic, sparingly soluble in water, freely soluble in alcohol and in methylene chloride
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IDENTIFICATION:
A] IR
B] TEST FOR SODIUM
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To comply
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To comply
2ml of filtrate gives reaction of sodium
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WATER |
NMT 2.0 per cent |
NMT 3.0 per cent |
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RESIDUE ON IGNITION |
15.5% to 16.5%,w/w |
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HEAVY METALS
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NMT 0.001% |
Not more than 10ppm.
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LIMIT OF BIS (2-ETHYLHEXYL) MALEATE
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NMT 0.4% |
NMT 0.4 % |
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ASSAY |
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NMT 0.2 ml of 0.1 M hydrochloric acid is required for neutralization. |
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CHLORIDES |
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NMT 350 ppm. |
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SODIUM SULPHATE |
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NMT 2%. |
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DOCUSATE SODIUM POWDER(Docusate Sodium USP/BP 85%,Sodium Benzoate NF 15%) |
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TESTS |
LIMITS |
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DESCRIPTION |
White to off-white free flowing powder. |
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RESIDUE ON IGNITION |
Between 19.2%and 24.1%, calculated on anhydrous basis |
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HEAVY METALS |
Not more than 0.001%. |
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WATER(LOSS ON DRYING) |
Not more than 2.0 per cent. |
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HEAVY METALS |
Not more than 0.001% |
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ASSAY(HPLC)
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82.0% to 88.0%w/w |
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SODIUM BENZOATE
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12.0% to 18%w/w |
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DOCUSATE SODIUM LIQUID(Docusate Sodium USP/BP 50% PEG400 50%) |
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TESTS |
LIMITS |
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DESCRIPTION |
White to yellow, clear, viscous liquid, free from suspended solids |
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SPECIFIC GRAVITY @ 25°C |
1.00 - 1.30g/ml |
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HEAVY METALS |
Not more than 0.001%. |
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WATER |
Not more than 2.0 per cent. |
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ASSAY |
Not less than 48% |
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DOCUSATE SODIUM LIQUID(Docusate Sodium USP/BP 75% Isopropyl Alcohol 25)
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TESTS |
LIMITS |
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DESCRIPTION |
White to yellow, clear, viscous liquid, free from suspended solids |
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SPECIFIC GRAVITY @ 25°C |
1.00 - 1.20g/ml |
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HEAVY METALS |
Not more than 0.001%. |
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WATER |
Not more than 2.0 per cent. |
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ASSAY |
74% |
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