{"id":21412,"date":"2025-10-28T15:15:50","date_gmt":"2025-10-28T08:15:50","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=21412"},"modified":"2025-10-28T15:15:50","modified_gmt":"2025-10-28T08:15:50","slug":"sodium-picosulfate-oral-drops","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/sodium-picosulfate-oral-drops\/","title":{"rendered":"Sodium Picosulfate Oral Drops"},"content":{"rendered":"<p>Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n<p><strong>Action and use <\/strong><\/p>\n<p>Stimulant laxative.<\/p>\n<h2>DEFINITION<\/h2>\n<p>Sodium Picosulfate Oral Drops are a solution of Sodium Picosulfate in a suitable vehicle in a suitable device fitted with an appropriate measuring system.<\/p>\n<p><em>The oral drops complies with the requirements stated under Oral Liquids and with the following requirements.<\/em><\/p>\n<p><strong>Content of sodium picosulfate, C<sub>18<\/sub>H<sub>13<\/sub>NNa<sub>2<\/sub>O<sub>8<\/sub>S<sub>2<\/sub><\/strong><\/p>\n<p>95.0 to 105.0% of the stated amount.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>A. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.<\/p>\n<p>(1) Dilute, if necessary, a volume of the oral drops with sufficient methanol to produce a solution containing 0.1% w\/v of Sodium Picosulfate.<\/p>\n<p>(2) 0.1% w\/v of sodium picosulfate BPCRS in methanol.<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>(a) Use as the coating silica gel F254 (Merck HPTLC plates are suitable).<\/p>\n<p>(b) Use the mobile phase as described below.<\/p>\n<p>(c) Apply 5 \u00b5L of each solution.<\/p>\n<p>(d) Develop the plate to 8 cm.<\/p>\n<p>(e) After removal of the plate, dry in air and examine immediately under ultraviolet light (254 nm). Spray with a 20% w\/v solution of hydrochloric acid in methanol and heat at 110\u00b0 for 10 minutes. Spray the hot plate with a freshly prepared solution containing 5% w\/v of iron(III) chloride and 0.1% w\/v of potassium hexacyanoferrate(III) and examine the wet plate in daylight.<\/p>\n<h3>MOBILE PHASE<\/h3>\n<p>2.5 volumes of anhydrous formic acid, 12.5 volumes of water, 25 volumes of methanol and 60 volumes of ethyl acetate.<\/p>\n<h3>CONFIRMATION<\/h3>\n<p>Under ultraviolet light (254 nm) The principal spot in the chromatogram obtained with solution (1) is similar in position and size to that in the chromatogram obtained with solution (2).<\/p>\n<p>After spraying The principal spot in the chromatogram obtained with solution (1) is similar in position, size and colour to that in the chromatogram obtained with solution (2).<\/p>\n<p>B. In the Assay, the retention time of the principal peak in the chromatogram obtained with solution (1) is similar to that of the peak in the chromatogram obtained with solution (2).<\/p>\n<h2>TESTS<\/h2>\n<p><strong>Impurity A<\/strong><\/p>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n<p>(1) Dilute, if necessary, a volume of the oral drops with sufficient water to produce a solution containing 0.005% w\/v of Sodium Picosulfate.<\/p>\n<p>(2) 0.0001% w\/v of sodium picosulfate BPCRS in water.<\/p>\n<p>(3) Dissolve 10 mg of sodium picosulfate BPCRS in 2 mL of 0.1M hydrochloric acid, bring rapidly to the boil and heat for 1 minute. Cool in ice-water, add 2 mL of 0.1M sodium hydroxide and dilute to 10 mL with the mobile phase. Dilute 1 volume to 25 volumes with the mobile phase (generation of impurity A).<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>(a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with base-deactivated end-capped octylsilyl silica gel for chromatography (5 \u00b5m) (YMC Basic is suitable).<\/p>\n<p>(b) Use isocratic elution and the mobile phase described below.<\/p>\n<p>(c) Use a flow rate of 2 mL per minute.<\/p>\n<p>(d) Use an ambient column temperature.<\/p>\n<p>(e) Use a detection wavelength of 263 nm.<\/p>\n<p>(f) Inject 50 \u00b5L of each solution.<\/p>\n<h3>MOBILE PHASE<\/h3>\n<p>380 volumes of acetonitrile and 620 volumes of a buffer solution containing 3.0 g disodium hydrogen orthophosphate and 0.5 g cetyltrimethylammonium bromide in 1000 mL of water, adjusting the final pH to 5.0 with orthophosphic acid.<\/p>\n<p>When the chromatograms are recorded under the prescribed conditions the retention time relative to sodium picosulfate (retention time about 26 minutes) is impurity A, about 0.2.<\/p>\n<h3>SYSTEM SUITABILITY<\/h3>\n<p>The test is not valid unless, the chromatogram obtained with solution (3), closely resembles the appropriate reference chromatogram supplied with sodium picosulfate BPCRS.<\/p>\n<h3>LIMITS<\/h3>\n<p>In the chromatogram obtained with solution (1) the area of any peak due to impurity A is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (2.0%).<\/p>\n<h2>ASSAY<\/h2>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n<p>(1) Dilute, if necessary, a volume of the oral drops with sufficient water to produce a solution containing 0.005% w\/v of Sodium Picosulfate.<\/p>\n<p>(2) 0.005% w\/v of sodium picosulfate BPCRS in water.<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>The chromatographic procedure described under the test for Impurity A may be used.<\/p>\n<h3>DETERMINATION OF CONTENT<\/h3>\n<p>Calculate the content of sodium picosulfate, C<sub>18<\/sub>H<sub>13<\/sub>NNa<sub>2<\/sub>O<sub>8<\/sub>S<sub>2<\/sub>, in the oral drops from the chromatograms obtained and using the declared content of C<sub>18<\/sub>H<sub>13<\/sub>NNa<sub>2<\/sub>O<sub>8<\/sub>S<sub>2<\/sub> in sodium picosulfate BPCRS.<\/p>\n<h2>STORAGE<\/h2>\n<p>Sodium Picosulfate Oral Drops should be kept in an airtight container and protected from light.<\/p>\n<h2>IMPURITIES<\/h2>\n<p>The impurity limited by the requirements of this monograph is:<\/p>\n<p>A. 4-[(RS)-(4-Hydroxyphenyl)(pyridin-2-yl)methyl]phenyl sodium sulfate.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Stimulant laxative. DEFINITION Sodium Picosulfate Oral Drops are a solution of Sodium Picosulfate in a suitable vehicle in a suitable device fitted with an appropriate measuring system. The oral drops complies with the requirements stated under Oral Liquids and with the following requirements. Content of&#8230;<\/p>\n","protected":false},"author":5,"featured_media":21413,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-21412","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-formulated-preparations-specific-monographs"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/21412","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\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=21412"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/21412\/revisions"}],"predecessor-version":[{"id":21416,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/21412\/revisions\/21416"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/21413"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=21412"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=21412"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=21412"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}