Sodium Picosulfate BP Ph Eur
C18H13NNa2O8S2,H2Oıı499.4ıı10040-45-6
(anhydrous)
Action and use: Stimulant laxative.
DEFINITION
Sodium picosulfate contains not less than 98.5 per cent and not more than the
equivalent of 100.5 per cent of 4,4'-(pyridin-2-ylmethylene)bisphenyl bis(sodium
sulphate), calculated with reference to the anhydrous substance.
CHARACTERS
A white or almost white, crystalline powder, freely soluble in water, slightly
soluble in alcohol.
IDENTIFICATION
First identification A, E.
Second identification B, C, D, E.
A. Examine by infrared absorption spectrophotometry, comparing with the spectrum
obtained with sodium picosulfate CRS. Examine the substances prepared as discs.
B. Examine the chromatograms obtained in the test for related substances in
ultraviolet light
B. Examine the chromatograms obtained in the test for related substances in
ultraviolet light at 254 nm. 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).
C. To 5 ml of solution S (see Tests) add 1 ml of dilute hydrochloric acid and heat
to boiling. Add 1 ml of barium chloride solution. A white precipitate is formed.
D. To about 10 mg add 3 ml of sulphuric acid and 0.1 ml of potassium dichromate
solution. A violet colour develops.
E. The solution S gives reaction (a) of sodium.
TESTS
Solution S: Dissolve 2.5 g in distilled water and dilute to 50 ml with the
same solvent.
Appearance of solution: Solution S is clear and not more intensely coloured
than reference solution.
Acidity or alkalinity: To 10 ml of solution S add 0.05 ml of phenolphthalein
solution. The solution is colourless. Not more than 0.25 ml of 0.01 M sodium
hydroxide is required to change the colour of the indicator to pink.
Related substances: To pass the test.
Chlorides: Dilute 5 ml of solution S to 15 ml with water. The solution
complies with the limit test for chlorides (200 ppm).
Sulphates: Dilute 7.5 ml of solution S to 15 ml with distilled water. The
solution complies with the limit test for sulphates (400 ppm).
Heavy metals: 12 ml of solution S complies with limit test A for heavy metals
(20 ppm). Prepare the standard using 10 ml of lead standard solution (1 ppm Pb).
Water: 3.0 per cent to 5.0 per cent, determined on 0.500 g by the semi-micro
determination of water.
ASSAY
Dissolve 0.400 g in 80 ml of methanol. Titrate with 0.1 M perchloric acid,
determining the end-point potentiometrically. 1 ml of 0.1 M perchloric acid is
equivalent to 48.14 mg of C18H13NNa2O8S2.
IMPURITIES
A. R = SO3Na: 4-[(pyridin-2-yl)(4-hydroxyphenyl)methyl]phenyl sodium sulphate,
B. R = H: 4,4¢-[(pyridin-2-yl)methylene]bisphenol.
Sodium Picosulfate USP Grade
C18H13NNa2O8S2-H2O --- 499.42
C18H13NNa2O8S2 --- 481.41
4,4′-(2-Pyridylmethylene)diphenyl bis(hydrogen sulfate) disodium salt,
monohydrate;
Disodium 4,4′-(pyridin-2-ylmethanediyl)dibenzenesulfate
4,4′-(Pyridin-2-ylmethylene)bisphenyl bis(sodium sulfate), monohydrate ---
10040-45-6; UNII: VW106606Y8.
DEFINITION
Sodium Picosulfate contains NLT 98.5% and NMT 100.5% of sodium picosulfate
(C18H13NNa2O8S2), calculated on the anhydrous basis.
IDENTIFICATION
A. Infrared Absorption
B. Identification Tests—General, Sodium: Meets the requirements for the
pyroantimonate precipitate test
ASSAY
Sample solution: Dissolve 400 mg of Sodium Picosulfate in 80 mL of
methanol.
Analysis: Titrate with 0.1 N perchloric acid determining the endpoint
potentiometrically. Perform a blank determination, and make any necessary
correction. Each mL of 0.1 N perchloric acid is equivalent to 48.14 mg of sodium
picosulfate (C18H13NNa2O8S2).
Acceptance criteria: 98.5%–100.5% on the anhydrous basis
IMPURITIES
Chloride and Sulfate, Chloride: A 1.0-g portion shows no more
chloride than corresponds to 0.30 mL of 0.020 N hydrochloric acid: NMT 0.02%.
Chloride and Sulfate, Sulfate: A 500-mg portion shows no more
sulfate than corresponds to 0.20 mL of 0.020 N sulfuric acid: NMT 0.04%.
Organic Impurities: To pass the tests
Acidity and Alkalinity: To 10 mL of the portion of Sample solution retained
from the test for Color of Solution add a drop of phenolphthalein. The
solution is colorless. NMT 0.25 mL of 0.01 N sodium hydroxide is required to change
the color of the indicator to pink.
Water: 3.0%–5.0%.
Sodium Picosulfate USP Grade
C18H13NNa2O8S2-H2O --- 499.42
C18H13NNa2O8S2 --- 481.41
4,4′-(2-Pyridylmethylene)diphenyl bis(hydrogen sulfate) disodium salt,
monohydrate;
Disodium 4,4′-(pyridin-2-ylmethanediyl)dibenzenesulfate
4,4′-(Pyridin-2-ylmethylene)bisphenyl bis(sodium sulfate), monohydrate ---
10040-45-6; UNII: VW106606Y8.
DEFINITION
Sodium Picosulfate contains NLT 98.5% and NMT 100.5% of sodium picosulfate
(C18H13NNa2O8S2), calculated on the anhydrous basis.
IDENTIFICATION
A. Infrared Absorption
B. Identification Tests—General, Sodium: Meets the requirements for the
pyroantimonate precipitate test
ASSAY
Sample solution: Dissolve 400 mg of Sodium Picosulfate in 80 mL of
methanol.
Analysis: Titrate with 0.1 N perchloric acid determining the endpoint
potentiometrically. Perform a blank determination, and make any necessary
correction. Each mL of 0.1 N perchloric acid is equivalent to 48.14 mg of sodium
picosulfate (C18H13NNa2O8S2).
Acceptance criteria: 98.5%–100.5% on the anhydrous basis
IMPURITIES
Chloride and Sulfate, Chloride: A 1.0-g portion shows no more
chloride than corresponds to 0.30 mL of 0.020 N hydrochloric acid: NMT 0.02%.
Chloride and Sulfate, Sulfate: A 500-mg portion shows no more
sulfate than corresponds to 0.20 mL of 0.020 N sulfuric acid: NMT 0.04%.
Organic Impurities: To pass the tests
Acidity and Alkalinity: To 10 mL of the portion of Sample solution retained
from the test for Color of Solution add a drop of phenolphthalein. The
solution is colorless. NMT 0.25 mL of 0.01 N sodium hydroxide is required to change
the color of the indicator to pink.
Water: 3.0%–5.0%.
