{"id":29991,"date":"2025-11-11T14:26:05","date_gmt":"2025-11-11T07:26:05","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=29991"},"modified":"2025-11-11T14:26:05","modified_gmt":"2025-11-11T07:26:05","slug":"sodium-picosulfate","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/sodium-picosulfate\/","title":{"rendered":"Sodium Picosulfate"},"content":{"rendered":"<p><em>(Ph. Eur. monograph 1031)<\/em><\/p>\n<p>C<sub>18<\/sub>H<sub>13<\/sub>NNa<sub>2<\/sub>O<sub>8<\/sub>S<sub>2<\/sub>,H<sub>2<\/sub>O 499.4<\/p>\n<p><strong>Action and use<\/strong><\/p>\n<p>Stimulant laxative.<\/p>\n<p><strong>Preparations<\/strong><\/p>\n<p>Compound Sodium Picosulfate Powder for Oral Solution<\/p>\n<p>Sodium Picosulfate Oral Solution Drops<\/p>\n<p>Sodium Picosulfate Oral Solution<\/p>\n<h2>DEFINITION<\/h2>\n<p><span style=\"font-size: 14.4px;\">4,4\u2032-[(Pyridin-2-yl)methylene]diphenyl bis(sodium sulfate) monohydrate.<\/span><\/p>\n<h3>Content<\/h3>\n<p><span style=\"font-size: 14.4px;\">98.5 per cent to 100.5 per cent (anhydrous substance).<\/span><\/p>\n<h2>CHARACTERS<\/h2>\n<h3>Appearance<\/h3>\n<p>White or almost white, crystalline powder.<\/p>\n<h3>Solubility<\/h3>\n<p>Freely soluble in water, slightly soluble in ethanol (96 per cent).<span style=\"font-size: 14.4px;\">IDENTIFICATION<\/span><\/p>\n<p>First identification: A, D.<\/p>\n<p>Second identification: B, C, D.<\/p>\n<p>A. Infrared absorption spectrophotometry (2.2.24).<\/p>\n<p>Comparison: sodium picosulfate CRS.<\/p>\n<p>B. Thin-layer chromatography (2.2.27).<\/p>\n<p>Test solution: Dissolve 20 mg of the substance to be examined in methanol R and dilute to 5 mL with the same solvent.<\/p>\n<p>Reference solution: Dissolve 20 mg of sodium picosulfate CRS in methanol R and dilute to 5 mL with the same solvent.<\/p>\n<p>Plate: TLC silica gel GF254 plate R.<\/p>\n<p>Mobile phase: anhydrous formic acid R, water R, methanol R, ethyl acetate R (2.5:12.5:25:60 V\/V\/V\/V).<\/p>\n<p>Application: 5 \u03bcL.<\/p>\n<p>Development: Over 1\/2 of the plate.<\/p>\n<p>Drying: In a current of warm air for 15 min.<\/p>\n<p>Detection: Examine in ultraviolet light at 254 nm.<\/p>\n<p>Results: The principal spot in the chromatogram obtained with the test solution is similar in position and size to the principal spot in the chromatogram obtained with the reference solution.<\/p>\n<p>C. To 5 mL of solution S (see Tests) add 1 mL of dilute hydrochloric acid R and heat to boiling. Add 1 mL of barium chloride solution R1. A white precipitate is formed.<\/p>\n<p>D. Solution S gives reaction (a) of sodium (2.3.1).<\/p>\n<h2>TESTS<\/h2>\n<h3>Solution S<\/h3>\n<p>Dissolve 2.5 g in carbon dioxide-free water R prepared from distilled water R and dilute to 50 mL with the same solvent.<\/p>\n<h3>Appearance of solution<\/h3>\n<p>Solution S is clear (2.2.1) and not more intensely coloured than reference solution GY7 <span style=\"font-size: 14.4px;\">(2.2.2, Method II).<\/span><\/p>\n<h3>Acidity or alkalinity<\/h3>\n<p>To 10 mL of solution S add 0.05 mL of phenolphthalein solution R. 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.<\/p>\n<h3>Related substances<\/h3>\n<p>Liquid chromatography (2.2.29).<\/p>\n<p>Test solution: Dissolve 50 mg of the substance to be examined in the mobile phase and dilute to 100.0 mL with the mobile phase.<\/p>\n<p>Reference solution (a): Dilute 1.0 mL of the test solution to 100.0 mL with the mobile phase. Dilute 10.0 mL of this solution <span style=\"font-size: 14.4px;\">to 100.0 mL with the mobile phase.<\/span><\/p>\n<p>Reference solution (b): Dissolve the contents of a vial of picosulfate for system suitability CRS (containing impurities A and B) in 1.0 mL of the mobile phase.<\/p>\n<p>Column:<\/p>\n<p>\u2014 size: l = 0.25 m, \u00d8 = 4.0 mm;<\/p>\n<p>\u2014 stationary phase: spherical end-capped octadecylsilyl silica gel for chromatography R1 (5 \u03bcm);<\/p>\n<p>\u2014 temperature: 40 \u00b0C.<\/p>\n<p>Mobile phase: Dissolve 2.3 g of disodium hydrogen phosphate dihydrate R in 800 mL of water for chromatography R, add 0.2 g of cetyltrimethylammonium bromide R, adjust to pH 7.5 with phosphoric acid R and dilute to 1000 mL with water for chromatography R; mix 550 mL of this solution and 450 mL of acetonitrile R (if necessary vary the buffer\/acetonitrile proportion in 10 mL increments in order to fulfil the resolution requirement).<\/p>\n<p>Flow rate: 1.0 mL\/min.<\/p>\n<p>Detection: Spectrophotometer at 263 nm.<\/p>\n<p>Injection: 40 \u03bcL.<\/p>\n<p>Run time: Twice the retention time of picosulfate.<\/p>\n<p>Identification of impurities: Use the chromatogram supplied with picosulfate for system suitability CRS and the chromatogram obtained with reference solution (b) to identify the peaks due to impurities A and B.<\/p>\n<p>Relative retention: With reference to picosulfate (retention time = about 7.4 min): impurity B = about 0.5; impurity A = about 0.7.<\/p>\n<p>System suitability: Reference solution (b):<\/p>\n<p>\u2014 resolution: minimum 4.0 between the peaks due to impurities B and A.<\/p>\n<p>Limits:<\/p>\n<p>\u2014 correction factors: for the calculation of content, multiply the peak areas of the following impurities by the corresponding correction factor: impurity A = 0.7; impurity B = 0.5;<\/p>\n<p>\u2014 impurities A, B: for each impurity, not more than twice the area of the principal peak in the chromatogram obtained with reference solution (a) (0.2 per cent);<\/p>\n<p>\u2014 unspecified impurities: for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (a) (0.10 per cent);<\/p>\n<p>\u2014 total: not more than 5 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.5 per cent);<\/p>\n<p>\u2014 disregard limit: 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.05 per cent).<\/p>\n<h3>Chlorides (2.4.4)<\/h3>\n<p>Maximum 200 ppm.<\/p>\n<p>Dilute 5 mL of solution S to 15 mL with water R.<\/p>\n<h3>Sulfates (2.4.13)<\/h3>\n<p>Maximum 400 ppm.<\/p>\n<p>Dilute 7.5 mL of solution S to 15 mL with distilled water R.<\/p>\n<h3>Water (2.5.12)<\/h3>\n<p>3.0 per cent to 5.0 per cent, determined on 0.500 g.<\/p>\n<h2>ASSAY<\/h2>\n<p>Dissolve 0.400 g in 80 mL of methanol R. Titrate with 0.1 M perchloric acid, determining the end-point potentiometrically (2.2.20).<\/p>\n<p>1 mL of 0.1 M perchloric acid is equivalent to 48.14 mg of C<sub>18<\/sub>H<sub>13<\/sub>NNa<sub>2<\/sub>O<sub>8<\/sub>S<sub>2<\/sub>.<\/p>\n<h2>IMPURITIES<\/h2>\n<p>Specified impurities A, B.<\/p>\n<p>Other detectable impurities (the following substances would, if present at a sufficient level, be detected by one or other of the tests in the monograph. They are limited by the general acceptance criterion for other\/unspecified impurities and\/or by the general monograph Substances for pharmaceutical use (2034). It is therefore not necessary to identify these impurities for demonstration of compliance. See also 5.10. Control of impurities in substances for pharmaceutical use) C.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-30008\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/2-71-300x163.jpg\" alt=\"Sodium Picosulfate\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/2-71-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/2-71-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/2-71-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/2-71.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>A. 4-[(RS)-(4-hydroxyphenyl)(pyridin-2-yl)methyl]phenyl sodium sulfate,<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-30009\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/3-70-300x163.jpg\" alt=\"Sodium Picosulfate\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/3-70-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/3-70-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/3-70-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/3-70.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>B. 4,4\u2032-[(pyridin-2-yl)methylene]diphenol,<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-30010\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/4-68-300x163.jpg\" alt=\"Sodium Picosulfate\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/4-68-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/4-68-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/4-68-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/4-68.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>C. 2-[(RS)-(pyridin-2-yl)[4-(sulfonatooxy)phenyl]methyl]phenyl disodium sulfate.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>(Ph. Eur. monograph 1031) C18H13NNa2O8S2,H2O 499.4 Action and use Stimulant laxative. Preparations Compound Sodium Picosulfate Powder for Oral Solution Sodium Picosulfate Oral Solution Drops Sodium Picosulfate Oral Solution DEFINITION 4,4\u2032-[(Pyridin-2-yl)methylene]diphenyl bis(sodium sulfate) monohydrate. Content 98.5 per cent to 100.5 per cent (anhydrous substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Freely soluble in&#8230;<\/p>\n","protected":false},"author":4,"featured_media":30007,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-29991","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicinal-substances"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/29991","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=29991"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/29991\/revisions"}],"predecessor-version":[{"id":30013,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/29991\/revisions\/30013"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/30007"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=29991"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=29991"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=29991"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}