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Sodium Picosulfate

Bulk Active : Sodium Picosulfate
MOLECULAR FORMULA : C18H13NNa2O8S2,H2O
MOLECULAR WEIGHT : 499.4
Pharmacologic Activity : Laxative
CAS No : 10040-45-6
Specifications : BP/EP
Regulatory compliance : eDMF(CTD)

TESTS EP 7.4/BP 2013
   
Appearance White or almost white, crystalline powder
   
Solubility Freely soluble in water, slightly soluble in ethanol (96%).
   

IDENTIFICATION
Test A : IR


Test B : T.L.C



Test C:

Test D:

Test E:



Infrared absorption spectrum of sample should be concordant with the reference spectrum of Sodium Picosulphate reference standard.

The principal spot in the chromatogram obtained with
test solution (b) is similar in position and size to the principal
spot in the chromatogram obtained with reference solution (a).

A white precipitate is formed.

A violet colour develops.

The solution S gives reaction of sodium
   
Appearance of solution Solution S is clear and not more intensely colored
than reference solution GY7
   
Acidity or alkalinity Not more than 0.25 ml of 0.01 M sodium hydroxide
Is required to change the colour of the indicator to pink
   
Related substance (HPLC)
Impurity A
Impurity B
Unspecified Impurities
Total Impurity
NMT 0.2 per cent;
NMT 0.2 per cent;
NMT 0.10 %
NMT 0.5 per cent;
   
Chlorides Maximum 200 ppm.
   
Sulphates Maximum 400 ppm.
   
Water content 3.0 % to 5.0%.
   
Assay Between 98.5% and 100.5% of C18H13NNa2O8S2
calculated on anhyrous basis
   
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