{"id":4882,"date":"2025-09-28T20:42:16","date_gmt":"2025-09-28T13:42:16","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=4882"},"modified":"2025-09-29T16:21:25","modified_gmt":"2025-09-29T09:21:25","slug":"benzydamine-mouthwash","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/benzydamine-mouthwash\/","title":{"rendered":"Benzydamine Mouthwash"},"content":{"rendered":"<p>Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n<p><strong>Action and use<\/strong><\/p>\n<p>Cyclo-oxygenase inhibitor; analgesic; anti-inflammatory.<\/p>\n<h2>DEFINITION<\/h2>\n<p>Benzydamine Mouthwash is a solution of Benzydamine Hydrochloride in a suitable flavoured and coloured vehicle.<\/p>\n<p>The mouthwash complies with the requirements stated under Oromucosal Preparations and with the following requirements.<\/p>\n<p>Content of benzydamine hydrochloride, C<sub>19<\/sub>H<sub>23<\/sub>N<sub>3<\/sub>O,HCl<\/p>\n<p>92.5 to 107.5% 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.<br \/>\n(1) Dilute the mouthwash, if necessary, with absolute ethanol to contain 0.15% w\/v of Benzydamine Hydrochloride.<br \/>\n(2) 0.15% w\/v of benzydamine hydrochloride BPCRS in absolute ethanol.<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>(a) Use a TLC silica gel F254 precoated plate (Merck silica gel 60 F254 plates are suitable).<br \/>\n(b) Use the mobile phase as described below.<br \/>\n(c) Apply 50 \u03bcL of each solution.<br \/>\n(d) Develop the plate to 15 cm.<br \/>\n(e) After removal of the plate, dry in air and examine under ultraviolet light (254 nm).<\/p>\n<h3>MOBILE PHASE<\/h3>\n<p>30 volumes of triethylamine and 80 volumes of toluene.<\/p>\n<h3>CONFIRMATION<\/h3>\n<p>The principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2).<\/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<p>TESTS<\/p>\n<p><strong>Acidity or alkalinity<\/strong><\/p>\n<p>5.0 to 7.0, Appendix V L.<\/p>\n<p><strong>1-Benzyl-1H-indazol-3-ol<\/strong><\/p>\n<p>Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.<br \/>\n(1) Extract a quantity of the mouthwash containing 15 mg of Benzydamine Hydrochloride with seven 90-mL quantities of chloroform. Filter each extract through phase separating paper, evaporate the combined extracts to dryness and dissolve the residue in 10 mL of methanol.<br \/>\n(2) 0.0015% w\/v of 1-benzyl-1H-indazol-3-ol BPCRS in methanol.<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>(a) Use a TLC silica gel F254 plate.<br \/>\n(b) Use the mobile phase as described below.<br \/>\n(c) Apply 20 \u03bcL of each solution.<br \/>\n(d) Develop the plate to 15 cm.<br \/>\n(e) After removal of the plate, dry in air and examine under ultraviolet light (365 nm).<\/p>\n<h3>MOBILE PHASE<\/h3>\n<p>10 volumes of glacial acetic acid, 20 volumes of chloroform and 70 volumes of cyclohexane.<\/p>\n<h3>LIMITS<\/h3>\n<p>Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2) (1%).<\/p>\n<h2>ASSAY<\/h2>\n<p>Carry out the method for gas chromatography, Appendix III B, using the following solutions. Prepare a 0.075% w\/v solution of 1-benzyl-3-(3-diethylamino-propoxy)-1H-indazole BPCRS (internal standard) in water (solution A).<br \/>\n(1) Add 10 mL of solution A, 5 mL of water, 5 mL of 1M sodium hydroxide and 20 mL of chloroform to a quantity of the mouthwash containing 7.5 mg of Benzydamine Hydrochloride, diluted, if necessary to 5 mL with water, shake for 5 minutes, centrifuge and use the chloroform layer.<br \/>\n(2) Prepare solution (2) in the same manner as solution (1) except using 5 mL of a solution containing 0.15% w\/v of benzydamine hydrochloride BPCRS in water in place of a quantity of the mouthwash containing 7.5 mg of Benzydamine Hydrochloride, diluted, if necessary, to 5 mL with water.<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>a) Use a glass column (2 m \u00d7 2 mm) packed with acid-washed, diatomaceous support (80 to 100 mesh) coated with 3% w\/w of phenyl methyl silicone fluid (50% phenyl) (OV-17 is suitable).<br \/>\n(b) Use nitrogen for chromatography as the carrier gas at 30 mL per minute.<br \/>\n(c) Use isothermal conditions maintained at 260\u00b0.<br \/>\n(d) Use an inlet temperature of 300\u00b0.<br \/>\n(e) Use a flame ionisation detector at 300\u00b0.<br \/>\n(f) Inject 1 \u03bcL of each solution.<\/p>\n<h3>DETERMINATION OF CONTENT<\/h3>\n<p>Calculate the content of C19H23N3O,HCl from the chromatograms obtained using the declared content of C<sub>19<\/sub>H<sub>23<\/sub>N<sub>3<\/sub>O,HCl in benzydamine hydrochloride BPCRS.<\/p>\n<h2>LABELLING<\/h2>\n<p>The label states, where appropriate, that the preparation is also suitable for use as a gargle.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Cyclo-oxygenase inhibitor; analgesic; anti-inflammatory. DEFINITION Benzydamine Mouthwash is a solution of Benzydamine Hydrochloride in a suitable flavoured and coloured vehicle. The mouthwash complies with the requirements stated under Oromucosal Preparations and with the following requirements. Content of benzydamine hydrochloride, C19H23N3O,HCl 92.5 to 107.5% of the&#8230;<\/p>\n","protected":false},"author":5,"featured_media":4883,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-4882","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\/4882","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=4882"}],"version-history":[{"count":5,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/4882\/revisions"}],"predecessor-version":[{"id":5776,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/4882\/revisions\/5776"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/4883"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=4882"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=4882"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=4882"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}