Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n
Action and use<\/strong><\/p>\n Cyclo-oxygenase inhibitor; analgesic; anti-inflammatory.<\/p>\n Benzydamine Oromucosal Spray is a solution of Benzydamine Hydrochloride in a suitable flavoured vehicle in a suitable metered-dose container.<\/p>\n The oromucosal spray complies with the requirements stated under Oromucosal Preparations and with the following requirements.<\/p>\n Content of benzydamine hydrochloride, C19<\/sub>H23<\/sub>N3<\/sub>O,HCl<\/strong><\/p>\n 92.5 to 107.5% of the stated amount.<\/p>\n A. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.<\/p>\n (1) Dilute the oromucosal spray, if necessary, with absolute ethanol to contain 0.15% w\/v of Benzydamine Hydrochloride.<\/p>\n (2) 0.15% w\/v of benzydamine hydrochloride BPCRS in absolute ethanol.<\/p>\n (a) Use a TLC silica gel F254 precoated plate (Merck silica gel 60 F254<\/sub> plates are suitable).<\/p>\n (b) Use the mobile phase as described below.<\/p>\n (c) Apply 50 \u03bcL of each solution.<\/p>\n (d) Develop the plate to 15 cm.<\/p>\n (e) After removal of the plate, dry in air and examine under ultraviolet light (254 nm).<\/p>\n 30 volumes of triethylamine and 80 volumes of toluene.<\/p>\n The principal spot in the chromatogram obtained with solution (1) corresponds 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 Acidity or alkalinity<\/strong><\/p>\n 5.0 to 7.0, Appendix V L.<\/p>\n Weigh one unit. Fire one shot and reweigh the unit. Repeat four times, then repeat the entire process with 3 more units (20 shots). Determine the average weight delivered per shot. Not more than two of the individual weights deviate from the average weight by more than 10% and none deviates by more than 20%.<\/p>\n 1-Benzyl-1H-indazol-3-ol<\/p>\n Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.<\/p>\n (1) Extract a quantity of the oromucosal spray 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.<\/p>\n (2) 0.0015% w\/v of 1-benzyl-1H-indazol-3-ol BPCRS in methanol.<\/p>\n (a) Use a TLC silica gel F254 plate.<\/p>\n (b) Use the mobile phase as described below.<\/p>\n (c) Apply 20 \u03bcL of each solution.<\/p>\n (d) Develop the plate to 15 cm.<\/p>\n (e) After removal of the plate, dry in air and examine under ultraviolet light (365 nm).<\/p>\n 10 volumes of glacial acetic acid, 20 volumes of chloroform and 70 volumes of cyclohexane.<\/p>\n 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 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).<\/p>\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 oromucosal spray 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.<\/p>\n (2) Prepare solution (2) in the same manner as solution (1) but using 5 mL of solution containing 0.15% w\/v of benzydamine hydrochloride BPCRS in water in place of a quantity of the oromucosal spray containing 7.5 mg of Benzydamine Hydrochloride, diluted, if necessary, to 5 mL with water.<\/p>\n (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).<\/p>\n (b) Use nitrogen for chromatography as the carrier gas at 30 mL per minute.<\/p>\n (c) Use isothermal conditions maintained at 260\u00b0.<\/p>\n (d) Use an inlet temperature of 300\u00b0.<\/p>\n (e) Use a flame ionisation detector at 300\u00b0.<\/p>\n (f) Inject 1 \u03bcL of each solution.<\/p>\n Calculate the content of C19<\/sub>H23<\/sub>N3<\/sub>O,HCl from the chromatograms obtained using the declared content of C19<\/sub>H23<\/sub>N3<\/sub>O,HCl in benzydamine hydrochloride BPCRS.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Cyclo-oxygenase inhibitor; analgesic; anti-inflammatory. DEFINITION Benzydamine Oromucosal Spray is a solution of Benzydamine Hydrochloride in a suitable flavoured vehicle in a suitable metered-dose container. The oromucosal spray complies with the requirements stated under Oromucosal Preparations and with the following requirements. Content of benzydamine hydrochloride, C19H23N3O,HCl…<\/p>\n","protected":false},"author":5,"featured_media":4103,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-4095","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\/4095","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=4095"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/4095\/revisions"}],"predecessor-version":[{"id":5120,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/4095\/revisions\/5120"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/4103"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=4095"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=4095"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=4095"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
IDENTIFICATION<\/h2>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
MOBILE PHASE<\/h3>\n
CONFIRMATION<\/h3>\n
TESTS<\/h2>\n
Uniformity of weight<\/h3>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
MOBILE PHASE<\/h4>\n
LIMITS<\/h4>\n
ASSAY<\/h2>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
DETERMINATION OF CONTENT<\/h3>\n