{"id":21858,"date":"2025-10-29T10:50:19","date_gmt":"2025-10-29T03:50:19","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=21858"},"modified":"2025-11-24T10:54:43","modified_gmt":"2025-11-24T03:54:43","slug":"ursodeoxycholic-acid-oral-suspension","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/ursodeoxycholic-acid-oral-suspension\/","title":{"rendered":"Ursodeoxycholic Acid Oral Suspension"},"content":{"rendered":"<p><strong>Action and use<\/strong><\/p>\n<p>Bile acid; treatment of gallstones.<\/p>\n<h2>DEFINITION<\/h2>\n<p>Ursodeoxycholic Acid Oral Suspension is a suspension of Ursodeoxycholic Acid in a suitable vehicle.<\/p>\n<p>The oral suspension complies with the requirements stated under Oral Liquids and with the following requirements.<\/p>\n<h3>Content of ursodeoxycholic acid, C<sub>24<\/sub>H<sub>40<\/sub>O<sub>4<\/sub><\/h3>\n<p>95.0 to 105.0% of the stated amount.<\/p>\n<p>Shake the oral suspension vigorously before carrying out the following tests.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>A. Weigh a quantity of the oral suspension containing 50 mg of Ursodeoxycholic Acid into a test tube, add 5 mL of sulfuric acid and allow to dissolve. Add 0.5 mL formaldehyde solution, allow to stand for 5 minutes and add 25 mL water. The suspension obtained is greyish-blue.<\/p>\n<p>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<h2>TESTS<\/h2>\n<h3>Acidity<\/h3>\n<p>pH, 3.8 to 5.2, Appendix V L.<\/p>\n<h3>Related substances<\/h3>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions in Solvent A.<\/p>\n<p>Solvent A: 20 volumes of methanol and 80 volumes of mobile phase.<\/p>\n<p>(1) Add a quantity of the oral suspension containing 250 mg of Ursodeoxycholic Acid to 15 mL of Solvent A and mix with the aid of ultrasound for 15 minutes. Dilute to 50 mL and filter (0.45-\u03bcm PVDF filter is suitable).<\/p>\n<p>(2) Dilute 1 volume of solution (1) to 100 volumes.<\/p>\n<p>(3) 0.5% w\/v of ursodeoxycholic acid impurity standard BPCRS and 0.0055% w\/v of chenodeoxycholic acid BPCRS (impurity A).<\/p>\n<p>(4) Dilute 1 volume of solution (2) to 10 volumes.<\/p>\n<p>CHROMATOGRAPHIC CONDITIONS<\/p>\n<p>(a) Use a stainless steel column (10 cm \u00d7 2.1 mm) packed with octadecylsilyl silica gel for chromatography (3 \u03bcm) (Uptisphere HDO C18 is suitable).<\/p>\n<p>(b) Use isocratic elution and the mobile phase described below.<\/p>\n<p>(c) Use a flow rate of 0.6 mL per minute.<\/p>\n<p>(d) Use a column temperature of 40\u00b0.<\/p>\n<p>(e) Use a refractive index detector.<\/p>\n<p>(f) Inject 8 \u03bcL of each solution.<\/p>\n<p>(g) For solution (1), allow the chromatography to proceed for 5 times the retention time of ursodeoxycholic acid.<\/p>\n<p>MOBILE PHASE<\/p>\n<p>25 volumes of acetonitrile, 34 volumes of methanol and 47 volumes of a solution prepared by dissolving 0.8 g of sodium dihydrogen orthophosphate dihydrate in 1000 mL of water and adjusting the pH to 3.0 with orthophosphoric acid.<\/p>\n<p>When the chromatograms are recorded under the prescribed conditions the retention time relative to ursodeoxycholic acid (retention time, about 5 minutes) are: 7-ketolithocholic acid (impurity F), about 1.3 and chenodeoxycholic acid, about 2.8.<\/p>\n<p>SYSTEM SUITABILITY<\/p>\n<p>The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to ursodeoxycholic acid and 7-ketolithocholic acid is at least 2.0.<\/p>\n<p>LIMITS<\/p>\n<p>In the chromatogram obtained with solution (1):<\/p>\n<p>the area of any peaks corresponding to chenodeoxycholic acid is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1.0%);<\/p>\n<p>the area of any other secondary peak is not greater than 0.2 times the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);<\/p>\n<p>the sum of the areas of any other secondary peaks is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1.0%).<\/p>\n<p>Disregard any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (4) (0.1%).<\/p>\n<h2>ASSAY<\/h2>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions in Solvent A, as described under Related substances.<\/p>\n<p>(1) Add a weighed quantity of the oral suspension containing 250 mg of Ursodeoxycholic Acid to 15 mL of Solvent A and mix with the aid of ultrasound for 15 minutes. Dilute to 50 mL and filter (0.45-\u03bcm PVDF filter is suitable).<\/p>\n<p>(2) 0.5% w\/v of ursodeoxycholic acid BPCRS.<\/p>\n<p>(3) 0.5% w\/v of ursodeoxycholic acid impurity standard BPCRS.<\/p>\n<p>CHROMATOGRAPHIC CONDITIONS<\/p>\n<p>The conditions described under Related substances may be used.<\/p>\n<p>SYSTEM SUITABILITY<\/p>\n<p>The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to ursodeoxycholic acid and 7-ketolithocholic acid is at least 2.0.<\/p>\n<p>DETERMINATION OF CONTENT<\/p>\n<p>Determine the weight per mL of the oral suspension, Appendix V G, and calculate the content of C<sub>24<\/sub>H<sub>40<\/sub>O<sub>4<\/sub>, weight in volume, using the declared content of C<sub>24<\/sub>H<sub>40<\/sub>O<sub>4<\/sub> in ursodeoxycholic acid BPCRS.<\/p>\n<h2>IMPURITIES<\/h2>\n<p>The impurities limited by the requirements of this monograph include A, D, E and F listed under Ursodeoxycholic Acid and the following:<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-21854\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Ursodeoxycholic-Acid-Capsules-1-300x163.jpg\" alt=\"Ursodeoxycholic Acid Capsules\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Ursodeoxycholic-Acid-Capsules-1-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Ursodeoxycholic-Acid-Capsules-1-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Ursodeoxycholic-Acid-Capsules-1-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Ursodeoxycholic-Acid-Capsules-1.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>1. 3,7,12-trioxo-(5\u03b2)-cholan-24-oic acid (dehydrocholic acid).<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Action and use Bile acid; treatment of gallstones. DEFINITION Ursodeoxycholic Acid Oral Suspension is a suspension of Ursodeoxycholic Acid in a suitable vehicle. The oral suspension complies with the requirements stated under Oral Liquids and with the following requirements. Content of ursodeoxycholic acid, C24H40O4 95.0 to 105.0% of the stated amount. Shake the oral suspension&#8230;<\/p>\n","protected":false},"author":2,"featured_media":21866,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-21858","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\/21858","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\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=21858"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/21858\/revisions"}],"predecessor-version":[{"id":21868,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/21858\/revisions\/21868"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/21866"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=21858"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=21858"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=21858"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}