Sodium Picosulfate BP Ph Eur USP Manufacturers Exporters |
| Aadhunik Industries is a manufacturing group company. Aadhunik Industries is pioneer manufacturers of Sodium Picosulfate, Specialty Chemicals, Pharmaceutical Excipients, Food Fragrance & Flavor chemicals in India. It has toll manufacturers and representatives in UAE, Europe, Canada & USA and agents & customers in all countries like USA, Canada, Europe, UAE, South Africa, Tanzania, Kenya, Egypt, Nigeria, Uganda, Turkey, Mexico, Brazil, Chile, Argentina, Dubai, Netherlands, Italy, Spain, Germany, Portugal, France, Malaysia, Indonesia, Thailand, Korea, Japan, Russia etc. |
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SDS MSDS of Sodium Picosulfate BP Ph Eur USP Manufacturers
Specifications of Sodium Picosulfate USP Grade Show/Hide Details
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%.
Specifications of Sodium Picosulfate BP Ph Eur Grade Show/Hide Details
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.
CAS Number 10040-45-6, Sodium Picosulfate BP Ph Eur USP manufacturers suppliers exporters at:
manufacturer supplier exporter
Aadhunik Industries
Ankleshwar Gujarat & Mumbai, India
TEL: (OFFICE) 91-22-23774610, 23723564.
e-mail: info@aadhunikindustries.com
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Ammonium Bromide ------- Aluminum Chloride ------- Aluminium Potassium Sulphate ------- Ammonium Chloride ------- Ammonium Persulfate------- Ammonium Phosphate Monobasic or Dibasic or Monoammonium Diammonium Phosphate ------- Barium Chloride ------- Benzyl Alcohol ------- Benzoic Acid ------- Boric Acid ------- Borax ------- Calcium Chloride ------- Calcium Oxide ------- Calcium Hydroxide ------- Calcium D Saccharate ------- Calcium Sulfate ------- Chromic Chloride ------- Citric Acid ------- Cobalt Chloride ------- Copper Cupric Chloride ------- Copper Sulphate ------- Cuprous Chloride ------- Precipitated Coated & Directly Compressible Calcium Carbonate ------- Fumaric Acid ------- Ferric Chloride ------- HEDP ------- Isatoic Anhydride ------- Magnesium Chloride ------- Magnesium Sulphate ------- Maleic Acid ------- Malic Acid ------- Manganese Chloride ------- Manganese Sulphate ------- Phenyl Ethanol ------- Potassium Bromide ------- Potassium Bicarbonate ------- Potassium Carbonate ------- Potassium Chloride ------- Potassium Hydroxide Pellets ------- Potassium Phosphate Monobasic Dibasic Tribasic ------- Propylene Carbonate ------- Sodium Acetate ------- Sodium Diacetate ------- Sodium Hydroxide Pellets ------- Sodium Propionate ------- Sodium Thiosulfate ------- Sodium Formaldehyde Bisulfite ------- Sodium Phosphate Monobasic Dibasic Tribasic ------- Sodium Perborate ------- Sulfamic Acid ------- Tetra-basic zinc hydroxychloride -------- Urea Industrial Grade ------- Zinc Chloride