Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n
General Notices<\/p>\n
Action and use<\/b><\/p>\n
Stimulant laxative; faecal softener.<\/p>\n
DEFINITION<\/p>\n
Docusate Oral Solution contains 1.0% w\/v of Docusate Sodium in a suitable flavoured vehicle.<\/p>\n
The oral solution complies with the requirements stated under Oral Liquids and with the following requirements.<\/i><\/p>\n
Content of docusate sodium, C20<\/sub>H37<\/sub>NaO7<\/sub>S<\/b><\/p>\n 0.95 to 1.05% w\/v.<\/p>\n A. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.<\/p>\n (1) Pass a volume of the oral solution containing 10 mg of docusate sodium, with the aid of vacuum, through a solid phase extraction column of 1 mL capacity and containing 0.1 g of an octadecyl-bonded silica sorbent (a Sep-pak C18 column is suitable) which has been previously washed with 2 mL of methanol, followed by 5 mL of water. Wash the column with 2 mL of water, discarding the aqueous eluate and then elute the docusate sodium with 4 mL of methanol, retaining the methanol solution.<\/p>\n (2) 0.25% w\/v of docusate sodium BPCRS in methanol.<\/p>\n (a) Use as the coating silica gel G (Merck silica gel 60 plates are suitable).<\/p>\n (b) Use the mobile phase as described below.<\/p>\n (c) Apply 20 pL of each solution.<\/p>\n (d) Develop the plate to 15 cm.<\/p>\n (e) After removal of the plate, allow it to dry in air, expose to iodine vapour and examine in daylight.<\/p>\n 2 volumes of 13.5M ammonia, 20 volumes of ethanol (96%), 40 volumes of water and 50 volumes of ethyl acetate.<\/p>\n The principal spot in the chromatogram obtained with solution (1) corresponds in position and colour to that in the chromatogram obtained with solution (2).<\/p>\n B. In the Assay, the chromatogram obtained with solution (1) shows a peak with the same retention time as the principal peak in the chromatogram obtained with solution (2).<\/p>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1) Pass a weighed quantity of the oral solution containing 10 mg of docusate sodium, with the aid of vacuum, through a solid-phase extraction column of 1 mL capacity and containing 0.1 g of an octadecyl-bonded silica sorbent (a Sep-pak C18 column is suitable) previously washed with 2 mL of methanol, followed by 5 mL of water. Wash the column with 2 mL of water, discarding the aqueous eluate. Elute the docusate sodium with 4 mL of methanol and dilute to 20 mL with a mixture of 70 volumes of acetonitrile and 30 volumes of water.<\/p>\n (2) 0.05% w\/v of docusate sodium BPCRS in a mixture of 70 volumes of acetonitrile and 30 volumes of water.<\/p>\n (a) Use a stainless steel column (25 cm X 4.6 mm) packed with silica gel with a chemically bonded, strongly basic quaternary ammonium anion-exchange coating (10 pm) (Spherisorb SAX is suitable).<\/p>\n (b) Use isocratic elution and the mobile phase described below.<\/p>\n (c) Use a flow rate of 2 mL per minute.<\/p>\n (d) Use an ambient column temperature.<\/p>\n (e) Use a detection wavelength of 214 nm.<\/p>\n (f) Inject 20 pL of each solution.<\/p>\n 1.6 volumes of orthophosphoric acid, 350 volumes of water and 650 volumes of acetonitrile.<\/p>\n The test is not valid unless, in the chromatogram obtained with solution (2) the symmetry factor of the peak corresponding to docusate sodium is less than 1.5.<\/p>\n Determine the weight per mL of the oral solution, Appendix V G, and calculate the content of C20<\/sub>H37<\/sub>NaO7<\/sub>S, weight in volume, using the declared content of C20<\/sub>H37<\/sub>NaO7<\/sub>S in docusate sodium BPCRS.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) General Notices Action and use Stimulant laxative; faecal softener. DEFINITION Docusate Oral Solution contains 1.0% w\/v of Docusate Sodium in a suitable flavoured vehicle. The oral solution complies with the requirements stated under Oral Liquids and with the following requirements. Content of docusate sodium, C20H37NaO7S 0.95 to 1.05%…<\/p>\n","protected":false},"author":5,"featured_media":17198,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-17197","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\/17197","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=17197"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/17197\/revisions"}],"predecessor-version":[{"id":17202,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/17197\/revisions\/17202"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/17198"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=17197"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=17197"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=17197"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}IDENTIFICATION<\/h2>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
MOBILE PHASE<\/h3>\n
CONFIRMATION<\/h3>\n
ASSAY<\/h2>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
MOBILE PHASE<\/h3>\n
SYSTEM SUITABILITY<\/h3>\n
DETERMINATION OF CONTENT<\/h3>\n